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A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

Primary Purpose

Diabetic Nephropathies

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00489791
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathies focused on measuring Diabetic nephropathy, chronic kidney disease, PF-00489791, phosphodiesterase, PDE5

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
  • Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
  • Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.

Exclusion Criteria:

  • Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
  • Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%.
  • Subjects on combination ACE inhibitor/ARB therapy.

Sites / Locations

  • Saadat Ansari Internal Medicine
  • The Office of Iqbal Saeed MD, LLC
  • AKDHC Medical Research Services, LLC*
  • Southwest Clinical Research Institute, LLC
  • Southwest Clinical Research Institute, LLC
  • North America Research Institute
  • North American Research Institute / California Kidney Specialist
  • Citrus Dialysis Center
  • California Institute of Renal Research
  • Capital Nephrology Clinical Research
  • California Kidney Specialists
  • American Institute of Research
  • Whittier Internal Medicine Nephrology Medical Group
  • North Valley Nephrology
  • Riverside Clinical Research
  • Palm Springs Research Institute
  • ASA Clinical Research, LLC
  • Lakeview Medical Research
  • Rockdale Medical Research Associates
  • Renal Physicians of Georgia
  • Boise Kidney and Hypertension Institute
  • Chicago Clinical Research Institute, Inc.
  • Associates in Nephrology, SC
  • Research by Design, LLC
  • RenalCare Associates
  • Investigative Clinical Research of Indiana, LLC
  • Kansas Nephrology Research Institute, LLC
  • Four Rivers Clinical Research, Inc.
  • Crescent City Clinical Research Center
  • Northwest Louisiana Nephrology
  • Biolab Research, LLC
  • Alzohaili Medical Consultants
  • Apex Medical Research, AMR, Inc.
  • Apex Medical Research, MI, Inc.
  • Clinical Research Consultants, LLC
  • Lincoln Nephrology and Hypertension
  • Nebraska Nephrology Research Institute, LLC - Research Management, Inc.
  • Alliance Against Diabetes
  • Clinical Research Consortium
  • Jacobi Medical Center - Department of Medicine - Nephrology
  • Mountain Kidney and Hypertension Associates, PA
  • Trial Management Associates
  • Lake Medical Research
  • Northeast Clinical Research Center, LLC
  • Preferred Primary Care Physicians, Inc.
  • Columbia Nephrology Associates, PA
  • Carolina Nephrology, PA
  • Palmetto Nephrology, PA
  • South Carolina Nephrology & Hypertension Ctr, Inc
  • South Carolina Nephrology and Hypertension Center
  • Central Texas Kidney Associates
  • Research Management, Inc.
  • Diagnostic Clinic of Houston, PA
  • Houston Nephrology Research
  • Research Across America
  • Renal Associates, PA
  • San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
  • Nephrology Associates of Northern Virginia, Inc.
  • Nephrology Specialists, P.C.
  • Clinical Research Associates of Tidewater
  • Renal Remission & Hypertension Consultants, PLLC
  • Sound Medical Research
  • Renal Remission and Hypertension Clinic
  • Renal Research Practice
  • John Hunter Hospital
  • Department of Nephrology
  • Pharmacy Department
  • Melbourne Renal Research Group
  • Sheldon M Chumir Health Centre
  • University of Alberta Hospital
  • Entralogix Clincal Research Inc.
  • Entralogix Clinical Research Inc.
  • London Health Sciences Centre
  • Entralogix Clinical Research Inc.
  • N/A - formerly with Entralogix SMO
  • Sunnybrook Health Sciences Center
  • Centre de sante et de services sociaux champlain-Charles-Le Moyne
  • Centre de Dialyse de Bois de Boulogne
  • Hopital de Sacre Coeur de Montreal
  • Saskatoon Nephrology Group, Nurses Redisence
  • Saskatoon Nephrology Group, Nurses Residence
  • Saskatoon Nephrology Group
  • Aarhus Universitetshospital (Aarhus Sygehus)
  • Rigshospitalet
  • Steno Diabetes Center
  • Queen Mary Hospital
  • Division of Nephrology, Dept. of Medicine
  • Division of Nephrology
  • ICON Clinical Research
  • Prince of Wales Hospital
  • Apollo Hospitals
  • Gujarat Kidney Foundation
  • Shrushrut Clinical Research Association
  • P. D. Hinduja National Hospital and Medical Research Centre
  • Pfizer Centre
  • Deenanath Mangeshkar Hospital & Research Centre
  • Diabetes Care and Research Centre
  • KE.M Hospital Research Centre
  • King Edward Memorial Hospital
  • Jehangir Clinical Development Centre Pvt. Ltd.
  • Pharmacy
  • Seoul National University Bundang Hospital
  • Clinical Trial Pharmacy
  • Seoul National University Hospital
  • Samsung Medical Center, Department of Pharmacy
  • Samsung Medical Center,Sungkyunkwan Univ School of Medicine
  • Samsung Medical Center/Division of Nephrology
  • Boramae Medical Center/Division of Nephrology
  • SMG-SNU Boramae Medical Center
  • Universiti Sains Malaysia
  • Unit Kajian Klinikal, Hospital Universiti Sains Malaysia
  • Hospital Taiping
  • Clinical Research Centre, Hospital Pulau Pinang
  • Hospital Pulau Pinang
  • Nephrology Clinic, Queen Elizabeth Hospital
  • Unit Hemodialisis, Hospital Serdang
  • Comite Mexicano para la Prevencion de la Osteoporosis, A.C.
  • ICLE SC
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
  • Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis
  • Hospital Angeles del Pedregal
  • NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna
  • Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego
  • NZOZ PS "Medica"
  • Miedzyleski Szpital Specjalistyczny w Warszawie
  • Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow
  • Centrum Medyczne "OSTEOMED" NZOZ
  • Centrum Medyczne "Osteomed"
  • Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw
  • SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
  • Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases
  • Clinic for Nephrology, Military Medical Academy
  • Clinical Center of Serbia
  • Clinical Hospital Center "Zvezdara"
  • Clinical Hospital Center Zvezdara
  • Clinic for Endocrinology, Clinical Center Nis
  • FNsP Bratislava, Nemocnica Stare Mesto
  • Nemocnice s poliklinikami n.o.
  • Fakultna nemocnica s poliklinikou J.A.Reimana Presov
  • Vseobecna nemocnica Rimavska Sobota
  • Wits Clinical research
  • Worthwhile Clinical Trials (WWCT), Lake View Hospital
  • Dr. George Mukhari Hospital -University of Limpopo
  • Centre for Diabetes and Endocrinology
  • Latros International
  • Division of Nephrology and Hypertension, E13 Renal Unit
  • St Augustine's Hospital
  • Centre for Diabetes and Endocrinology
  • Centre for Diabetes and Endocrinology
  • Intercare Parow Medical and Dental Centre
  • Medi-Clinic Heart Hospital (Pretoria Heart Hospital)
  • Sahlgrenska University Hospital Njurmottagningen
  • A+ Science City site
  • Akademiska Sjukhuset
  • Doncaster Royal Infirmary
  • Research Offices (5th Floor)
  • University of Edinburgh
  • The Royal London Hospital Whitechapel
  • Guy's and St Thomas' Foundation Trust
  • Northern General Hospital Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-00489791

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.

Secondary Outcome Measures

Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).
Plasma Concentration Versus Time Summary of PF-00489791

Full Information

First Posted
September 10, 2010
Last Updated
February 18, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01200394
Brief Title
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Official Title
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2010 (Actual)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
Diabetic nephropathy, chronic kidney disease, PF-00489791, phosphodiesterase, PDE5

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-00489791
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-00489791
Intervention Description
Tablet, 20 mg once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet, placebo once daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12
Description
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units milligram per millimole (mg/mmol). A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 12], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 12]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Time Frame
Baseline, Week 12 (Day 5, 6, 7)
Secondary Outcome Measure Information:
Title
Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 3, 6 and 16
Description
UACR was ratio of albumin measured in urine (milligram) to creatinine measured in urine (millimole), reported in units mg/mmol. A decrease in UACR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of specified Week], and with last sample collected on the morning of scheduled clinic visit [Day 7 of specified Week]) were used to determine UACR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UACR.
Time Frame
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Title
Change From Baseline in Urinary Protein Creatinine Ratio (UPCR) at Week 3, 6, 12, and 16
Description
UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function. The mean values of the 3 consecutive first morning void urine samples (obtained 2 days prior to [Day 5, 6 of Week 3, 6, 12, 16], and with last sample collected on the morning of scheduled clinic visit [Day 7 of Week 3, 6, 12, 16]) were used to determine UPCR at the scheduled clinic visit. The mean values of the 3 consecutive first morning void urine samples obtained at screening were used to determine baseline UPCR.
Time Frame
Baseline, Week 3 (Day 5, 6, 7), Week 6 (Day 5, 6, 7), Week 12 (Day 5, 6, 7), Week 16 (Day 5, 6, 7)
Title
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 3, 6, 12, and 16
Description
The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration (sCr), age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 3, 6, 12, 16 (follow-up)
Title
Systolic, Diastolic and Mean Blood Pressure at Week 0, 3, 6, 12, and 16
Description
Systolic blood pressure (SBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle of heart. diastolic blood pressure (DBP) is the blood pressure (pressure exerted by circulating blood on the walls of blood vessels) when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles of heart. Mean blood pressure (MBP) = diastolic blood pressure + ([systolic blood pressure - diastolic blood pressure]/3). After a minimum of 5 minutes of rest, supine BP was measured with the participant's arm supported at the level of the heart.
Time Frame
Week 0, 3, 6, 12, 16 (follow-up)
Title
Change From Baseline in Serum Creatinine Concentration at Week 3, 6, 12, and 16
Description
Serum creatinine concentration was used as a marker of renal function. Baseline serum creatinine concentration was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 3, 6, 12, 16 (follow-up)
Title
Change From Baseline in Urine Transforming Growth Factor (TGF) Beta-1 Concentration at Week 3, 6, 12, and 16
Description
TGF Beta-1 is a major fibrogenic growth factor implicated in the pathogenesis of renal scarring. It is overexpressed in the diabetic kidney where it may promote matrix accumulation. Baseline TGF Beta-1 concentration was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 3, 6, 12, 16 (follow-up)
Title
Change From Baseline in Serum High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 12 and 16
Description
The CRP is an acute phase reactant which is virtually absent from the blood serum of healthy persons but rapidly appears in blood and body fluids in response to injurious stimuli. Baseline hs-CRP was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 12, 16 (follow-up)
Title
Change From Baseline in Serum Cystatin-C Concentration at Week 12 and 16
Description
Cystatin C is produced by all nucleated cells at a constant rate and is freely filtered at the glomerulus. The blood concentration of cystatin C depends almost entirely on the GFR and is not substantially affected by diet, nutritional status or inflammatory disease. Serum cystatin C had been proposed as an endogenous marker of GFR in participant with chronic kidney disease (CKD) than sCr. Baseline serum cystatin C was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 12, 16 (follow-up)
Title
Plasma Concentration Versus Time Summary of PF-00489791
Time Frame
Pre-dose at Day 1 of Week 0, 3, 6 and 12; 4 hours post-dose on Day 1 of Week 0, 3 and 6
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Plasma Glycosylated Hemoglobin (HbA1c) Level at Week 12 and 16
Description
Level of HbA1c is an indicator for the average level of blood glucose over the previous 3 months. Baseline HbA1c level was determined predose at Week 0 (Day 1).
Time Frame
Baseline, Week 12, 16 (follow-up)
Title
Number of Participants With Vital Signs Abnormalities
Description
Criteria for determining vital signs abnormalities: supine or standing systolic BP (SBP) (less than [<] 90 mmHg and increase or decrease of greater than or equal to [>=] 30 mmHg compared to baseline value), supine or standing diastolic BP (DBP) (<50 mmHg and increase or decrease of >=20 mmHg compared to baseline value), supine pulse rate (>120 beats per minute [bpm] or <40 bpm), standing pulse rate (>140 bpm or <40 bpm). For supine, baseline was the average of the triplicate predose readings at Week 0 (Day 1). For standing, baseline is the predose reading at Week 0 (Day 1). Only categories who had at least 1 participant are reported.
Time Frame
Baseline up to Week 16 (follow-up)
Title
Number of Participants With Edema and Fluid Overload
Description
Participants were assessed for signs of edema and fluid overload.
Time Frame
Week 0, 3, 6, 12, 16 (follow-up)
Title
Number of Participants With Increased Use of Diuretics
Time Frame
Baseline up to Week 16 (follow-up)
Title
Number of Participants With Laboratory Test Abnormalities
Description
Criteria for laboratory test abnormalities: Hematology (hemoglobin [<0.8*lower limit of normal{LLN}], hematocrit [<0.8*LLN], red blood cells [<0.8*LLN], platelet [<0.5*LLN/>1.75*upper limit of normal{ULN}], white blood cells [<0.6*LLN/>1.5*ULN], lymphocytes [<0.8*LLN/>1.2*ULN], neutrophils [<0.8*LLN/>1.2*ULN], basophils [>1.2*ULN], eosinophils [>1.2*ULN], monocytes [>1.2*ULN]); Liver Function (total/direct/indirect bilirubin [>1.5*ULN], aspartate aminotransferase/ alanine aminotransferase/ gamma glutamyl transpeptidase/ lactate dehydrogenase/ alkaline phosphatase [>3.0*ULN]); Renal Function (blood urea nitrogen/ creatinine [>1.3*ULN], uric acid [>1.2*ULN]); Electrolytes (sodium [<0.95*LLN/>1.05*ULN], potassium, chloride, calcium, bicarbonate [<0.9*LLN/>1.1*ULN]); Clinical Chemistry (glucose [<0.6*LLN/>1.5*ULN], glycosylated hemoglobin [>1.3*ULN], Creatine Kinase [>2.0*ULN], Amylase, Lipase[>1.5*ULN]).
Time Frame
Baseline up to Week 16 (follow-up)
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to Week 16 (follow-up) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-serious (AEs) and serious adverse events (SAEs)
Time Frame
Baseline up to Week 16 (follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential. Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2. Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months. Exclusion Criteria: Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD. Subjects with poorly controlled diabetes mellitus, defined as HbA1C >9%. Subjects on combination ACE inhibitor/ARB therapy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Saadat Ansari Internal Medicine
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
The Office of Iqbal Saeed MD, LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
AKDHC Medical Research Services, LLC*
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Southwest Clinical Research Institute, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Southwest Clinical Research Institute, LLC
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
North America Research Institute
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
North American Research Institute / California Kidney Specialist
City
Azusa
State/Province
California
ZIP/Postal Code
91702
Country
United States
Facility Name
Citrus Dialysis Center
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
California Institute of Renal Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Capital Nephrology Clinical Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
California Kidney Specialists
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
American Institute of Research
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Whittier Internal Medicine Nephrology Medical Group
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
North Valley Nephrology
City
Yuba
State/Province
California
ZIP/Postal Code
95991
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Palm Springs Research Institute
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
ASA Clinical Research, LLC
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Lakeview Medical Research
City
Summerfield
State/Province
Florida
ZIP/Postal Code
34491
Country
United States
Facility Name
Rockdale Medical Research Associates
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Renal Physicians of Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
Boise Kidney and Hypertension Institute
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Chicago Clinical Research Institute, Inc.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Associates in Nephrology, SC
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Research by Design, LLC
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
RenalCare Associates
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Investigative Clinical Research of Indiana, LLC
City
Elwood
State/Province
Indiana
ZIP/Postal Code
46036
Country
United States
Facility Name
Kansas Nephrology Research Institute, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Four Rivers Clinical Research, Inc.
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Crescent City Clinical Research Center
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Northwest Louisiana Nephrology
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Biolab Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Alzohaili Medical Consultants
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Apex Medical Research, AMR, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Apex Medical Research, MI, Inc.
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Lincoln Nephrology and Hypertension
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Nebraska Nephrology Research Institute, LLC - Research Management, Inc.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Alliance Against Diabetes
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89101
Country
United States
Facility Name
Clinical Research Consortium
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Jacobi Medical Center - Department of Medicine - Nephrology
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Mountain Kidney and Hypertension Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Trial Management Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lake Medical Research
City
Willoughby Hills
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Northeast Clinical Research Center, LLC
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc.
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
Columbia Nephrology Associates, PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Carolina Nephrology, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Palmetto Nephrology, PA
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
South Carolina Nephrology & Hypertension Ctr, Inc
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
South Carolina Nephrology and Hypertension Center
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Central Texas Kidney Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Research Management, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78751
Country
United States
Facility Name
Diagnostic Clinic of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Houston Nephrology Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Research Across America
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Renal Associates, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, P.L.L.C.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Nephrology Associates of Northern Virginia, Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Nephrology Specialists, P.C.
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116
Country
United States
Facility Name
Clinical Research Associates of Tidewater
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Renal Remission & Hypertension Consultants, PLLC
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Sound Medical Research
City
Port Orchard
State/Province
Washington
ZIP/Postal Code
98366
Country
United States
Facility Name
Renal Remission and Hypertension Clinic
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
Facility Name
Renal Research Practice
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Department of Nephrology
City
New Lambton
State/Province
Newcastle
ZIP/Postal Code
2305
Country
Australia
Facility Name
Pharmacy Department
City
New Lambton
State/Province
Newcastle
ZIP/Postal Code
2305
Country
Australia
Facility Name
Melbourne Renal Research Group
City
Reservoir
State/Province
Victoria
ZIP/Postal Code
3073
Country
Australia
Facility Name
Sheldon M Chumir Health Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 0X7
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Entralogix Clincal Research Inc.
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Z 4N5
Country
Canada
Facility Name
Entralogix Clinical Research Inc.
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Z 4N5
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Entralogix Clinical Research Inc.
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 3M5
Country
Canada
Facility Name
N/A - formerly with Entralogix SMO
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 5T2
Country
Canada
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre de sante et de services sociaux champlain-Charles-Le Moyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Centre de Dialyse de Bois de Boulogne
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3M 3E3
Country
Canada
Facility Name
Hopital de Sacre Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Saskatoon Nephrology Group, Nurses Redisence
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 2Z1
Country
Canada
Facility Name
Saskatoon Nephrology Group, Nurses Residence
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 2Z1
Country
Canada
Facility Name
Saskatoon Nephrology Group
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7M 2Z1
Country
Canada
Facility Name
Aarhus Universitetshospital (Aarhus Sygehus)
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen Oe
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Steno Diabetes Center
City
Gentofte
ZIP/Postal Code
2820
Country
Denmark
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Division of Nephrology, Dept. of Medicine
City
Pokfulam
Country
Hong Kong
Facility Name
Division of Nephrology
City
Pokfulam
Country
Hong Kong
Facility Name
ICON Clinical Research
City
Quarry Bay
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
ZIP/Postal Code
N.T. 0
Country
Hong Kong
Facility Name
Apollo Hospitals
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500096
Country
India
Facility Name
Gujarat Kidney Foundation
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 007
Country
India
Facility Name
Shrushrut Clinical Research Association
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 013
Country
India
Facility Name
P. D. Hinduja National Hospital and Medical Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400016
Country
India
Facility Name
Pfizer Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400102
Country
India
Facility Name
Deenanath Mangeshkar Hospital & Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 004
Country
India
Facility Name
Diabetes Care and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
KE.M Hospital Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
King Edward Memorial Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 011
Country
India
Facility Name
Jehangir Clinical Development Centre Pvt. Ltd.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Pharmacy
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Clinical Trial Pharmacy
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Samsung Medical Center, Department of Pharmacy
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Samsung Medical Center,Sungkyunkwan Univ School of Medicine
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Samsung Medical Center/Division of Nephrology
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Boramae Medical Center/Division of Nephrology
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of
Facility Name
Universiti Sains Malaysia
City
Kota Bharu
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Unit Kajian Klinikal, Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150,
Country
Malaysia
Facility Name
Hospital Taiping
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
Clinical Research Centre, Hospital Pulau Pinang
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Pulau Pinang
City
George Town
State/Province
Pulau Pinang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Nephrology Clinic, Queen Elizabeth Hospital
City
Kota Kinabalu
State/Province
Sabah
ZIP/Postal Code
88586
Country
Malaysia
Facility Name
Unit Hemodialisis, Hospital Serdang
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Facility Name
Comite Mexicano para la Prevencion de la Osteoporosis, A.C.
City
Mexico
State/Province
DF
ZIP/Postal Code
06100
Country
Mexico
Facility Name
ICLE SC
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (INCMNSZ)
City
Tlalpan
State/Province
Mexico CITY
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Hospital Central Dr Ignacio Morones Prieto Unidad Regional de Osteoporosis
City
San Luis Potosi
State/Province
San Luis
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Hospital Angeles del Pedregal
City
Angeles Del Pedregal Cp.
ZIP/Postal Code
10700
Country
Mexico
Facility Name
NZOZ "DIAGNOMED" S.C., Poradnia Nefrologiczna
City
Bielsko-Biala
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny im Andrzeja Mieleckiego
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
NZOZ PS "Medica"
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie
City
Warsaw
ZIP/Postal Code
4749
Country
Poland
Facility Name
Centrum Medyczne "Osteomed" NZOZ, Lecznica Specjalistow
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Centrum Medyczne "OSTEOMED" NZOZ
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Centrum Medyczne "Osteomed"
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
Centrum Medyczne OSTEOMED NZOZ; Lecznica Specjalistaw
City
Warszawa
ZIP/Postal Code
02-256
Country
Poland
Facility Name
SPZOZ Akademicki Szpital Kliniczny im. J. Mikulicza - Radeckiego
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
Facility Name
Clinical Center of Serbia Institute for Endocrinology, Diabetes and Metabolic Diseases
City
Belgrade
ZIP/Postal Code
11 000
Country
Serbia
Facility Name
Clinic for Nephrology, Military Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center "Zvezdara"
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zvezdara
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinic for Endocrinology, Clinical Center Nis
City
Nis
ZIP/Postal Code
18000
Country
Serbia
Facility Name
FNsP Bratislava, Nemocnica Stare Mesto
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Nemocnice s poliklinikami n.o.
City
Levice
ZIP/Postal Code
934 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou J.A.Reimana Presov
City
Presov
ZIP/Postal Code
081 81
Country
Slovakia
Facility Name
Vseobecna nemocnica Rimavska Sobota
City
Rimavska Sobota
ZIP/Postal Code
979 12
Country
Slovakia
Facility Name
Wits Clinical research
City
Johannesburg
State/Province
Gauteng- South Africa
ZIP/Postal Code
2096
Country
South Africa
Facility Name
Worthwhile Clinical Trials (WWCT), Lake View Hospital
City
Benoni
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Dr. George Mukhari Hospital -University of Limpopo
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0204
Country
South Africa
Facility Name
Centre for Diabetes and Endocrinology
City
Durban
State/Province
Kwazulu Natal
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Latros International
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Division of Nephrology and Hypertension, E13 Renal Unit
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
St Augustine's Hospital
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Centre for Diabetes and Endocrinology
City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Centre for Diabetes and Endocrinology
City
Houghton, Johannesburg
ZIP/Postal Code
2198
Country
South Africa
Facility Name
Intercare Parow Medical and Dental Centre
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Medi-Clinic Heart Hospital (Pretoria Heart Hospital)
City
Pretoria
ZIP/Postal Code
132
Country
South Africa
Facility Name
Sahlgrenska University Hospital Njurmottagningen
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
A+ Science City site
City
Stockholm
ZIP/Postal Code
111 57
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Research Offices (5th Floor)
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
University of Edinburgh
City
Edinburgh
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Facility Name
The Royal London Hospital Whitechapel
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Guy's and St Thomas' Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Northern General Hospital Campus
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7331011&StudyName=A%20Phase%202%2C%20Placebo-Controlled%20Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20PF-00489791%20In%20Patients%20With%20Type%202%20Diabetes%20And%20Overt%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

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