Back to resultsA Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Primary Purpose
Type 2 Diabetic Nephropathy
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-03882845
PF-03882845
PF-03882845
Spironolactone
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetic Nephropathy focused on measuring Type 2 diabetes mellitus. albuminuria.
Eligibility Criteria
Inclusion Criteria:
- Males and/or Females between 18-65 years, inclusive.
- Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
- Have type 2 diabetes mellitus.
- On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.
Exclusion Criteria:
- Recent evidence or medical history of unstable concurrent disease.
- Cardiovascular event within 3 months prior to screening.
- History of renal transplant.
- History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
PF03882845
Spironolactone
Placebo
Arm Description
25 mg once daily
Placebo once daily
Outcomes
Primary Outcome Measures
Change From Baseline in Serum Potassium at Day 8
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Change From Baseline in Serum Potassium at Day 15
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Number of Participants With Confirmed and Severe Hyperkalemia
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
Secondary Outcome Measures
Plasma Pharmacokinetic (PK) Parameters
PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15
Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
Change From Baseline in Sitting Pulse Rate at Day 15
Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01488877
Brief Title
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Official Title
A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (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-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.
Detailed Description
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetic Nephropathy
Keywords
Type 2 diabetes mellitus. albuminuria.
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF03882845
Arm Type
Experimental
Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
25 mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
3 mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
up to 10 mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
PF-03882845
Intervention Description
up to 30 mg once daily
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
spironolactone 25 mg once daily
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Serum Potassium at Day 8
Description
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 8 value calculated was average of 0 hours (immediately pre-dose) measurements on Day 7 and 8. Change from baseline values were presented under time point of Day 8.
Time Frame
Baseline, Day 7, 8
Title
Change From Baseline in Serum Potassium at Day 15
Description
Baseline value calculated as the average of -24 hours (pre-dose) measurement on Day -1 and 0 hours (immediately pre-dose) measurement on Day 1. Day 15 value calculated was average of 0 hours (immediately pre-dose) measurement on Day 14 and measurement obtained prior to discharge on Day 15. Change from baseline values were presented under time point of Day 15.
Time Frame
Baseline, Day 14, 15
Title
Number of Participants With Confirmed and Severe Hyperkalemia
Description
Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. Confirmed hyperkalemia is defined as serum potassium level greater than (>) upper limit of normal (ULN) of 5.4 mEq/L. Severe hyperkalemia is defined as serum potassium level >= 6.0 mEq/L. Number of participants with at least 1 confirmed or severe hyperkalemia is reported.
Time Frame
Baseline up to Day 15
Secondary Outcome Measure Information:
Title
Plasma Pharmacokinetic (PK) Parameters
Description
PK parameters were to be evaluated at Day 1 and Day 14 (steady state). Maximum observed plasma concentration (Cmax), time to reach maximum observed plasma concentration (Tmax), area under the curve from time zero to end of dosing interval (AUCtau) were to be evaluated at both Day 1 and Day 14 (steady state). Minimum observed plasma trough concentration (Cmin), average plasma concentration (Cavg), apparent oral clearance (CL/F), apparent volume of distribution (Vz/F) were to be evaluated only at Day 14 (steady state). Observed accumulation ratio (Rac) was also planned to be analyzed.
Time Frame
0 (pre-dose), 2, 4, 6, 8, 10, 14, 24 hours post-dose on Day 1, 14
Title
Change From Baseline in Sitting Systolic and Diastolic Blood Pressure at Day 15
Description
Systolic blood pressure (BP): BP when heart is contracting; maximum arterial pressure during contraction of left ventricle of heart. Diastolic blood pressure: BP when heart is relaxing; minimum arterial pressure during relaxation and dilation of ventricles of heart. A total of 3 measurements were performed; average of triplicate BP values collected pre-dose on Day 1 served as baseline. The same arm and same sized cuff (properly sized and calibrated) was used throughout the study, after participant sat for 5 minutes for the first measurement and 2 minutes for second and third measurements.
Time Frame
Day 1 (Baseline), 15
Title
Change From Baseline in Sitting Pulse Rate at Day 15
Description
Sitting pulse rate was measured in the brachial/radial artery for at least 30 seconds. A total of 3 measurements were performed; average of triplicate pulse rate values collected pre-dose on Day 1 served as baseline.
Time Frame
Day 1 (Baseline), 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and/or Females between 18-65 years, inclusive.
Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or greater than 110 lb.
Have type 2 diabetes mellitus.
On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.
Exclusion Criteria:
Recent evidence or medical history of unstable concurrent disease.
Cardiovascular event within 3 months prior to screening.
History of renal transplant.
History of hospitalization for acute kidney injury or acute kidney dialysis within 6 months prior to screening.
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
Pfizer Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pfizer Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0171011&StudyName=A%20Study%20To%20Evaluate%20The%20Safety%20And%20Tolerability%20Of%20PF-03882845%20In%20Patients%20With%20Type%202%20Diabetic%20Nephropathy
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
We'll reach out to this number within 24 hrs