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A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (PODO)

Primary Purpose

Focal Segmental Glomerulosclerosis (FSGS)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06730512
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis (FSGS) focused on measuring Proteinuria

Eligibility Criteria

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

Inclusion Criteria:

  1. Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS.
  2. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
  3. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
  4. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment.

Exclusion Criteria:

  1. Diagnosis of collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  3. Organ transplant.
  4. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years.
  5. Body mass index (BMI) greater than 45 kg/m2.
  6. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.

Sites / Locations

  • The Kirklin Clinic of University Alabama Birmingham Hospital
  • Investigational Drug Service Pharmacy UAB Hosptial
  • Clinical Research Unit at UAB Hospital
  • UAB Nephrology Research Clinic at Paula Building
  • Academic Medical Research Institute
  • Cedars Sinai Medical Center
  • Cedars-Sinai Ambulatory Infusion Center
  • Cedars-Sinai Comprehensive Transplant Center
  • Ronald Reagan UCLA Medical Center
  • UCLA Clinical and Translational Research Center
  • UCLA Department of Medicine
  • Clinical and Translation Research Unit
  • Stanford University-Nephrology Division
  • University of California, San Francisco
  • Stanford Health Care Investigational Pharmacy
  • Stanford University-Nephrology Division
  • Stanford University
  • Yale Center for Clinical Investigation Hospital Research Unit
  • Yale Nephrology Clinical Research Clinic
  • Yale University School of Medicine - Yale-New Haven Hospital
  • Yale University
  • Yale New Haven Hospital
  • Yale Center for Clinical Investigation - Church Street Research Unit
  • University of Miami Hospital and Clinics
  • University of Miami Katz Family Division of Nephrology
  • University of Miami
  • Georgia Nephrology Research Institute
  • Georgia Nephrology
  • University of Iowa Hospitals and Clinics
  • Johnson County Clin Trials
  • Boston Medical Center - Interventional Radiology
  • Boston Medical Center - Nephrology
  • Boston Medical Center
  • Boston University - GCRU
  • Henry Ford Hospital
  • Clinical Research Consultants, LLC
  • St. Luke's Hospital
  • New York University Grossman School of Medicine - CTSI
  • UNC Eastowne
  • UNC Clinical and Translational Research Center
  • University of Cincinnati at DCI McMillan Research Unit
  • Hoxworth Center Subspecialties Clinic
  • UC Health Barrett Center
  • UC Health Medical Arts Building
  • University of Cincinnati Gardner Neuroscience Institute
  • The Cleveland Clinic - Investigational Drug Pharmacy
  • The Cleveland Clinic
  • CarePoint East at The Ohio State University
  • The Ohio State University Clinical Research Center
  • The Ohio State University Investigational Drug Services
  • The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit
  • The Ohio State University
  • Kidney and Hypertension Care Center, PA
  • Southside Pharmacy
  • Prolato Clinical Research Center (PCRC)
  • Baylor Scott & White Clinic - Temple South Loop
  • University of Alberta - Pharmacy Research Office
  • University of Alberta - Clinical Investigation Unit
  • University of Alberta Hospital
  • Pacific Nephrology Group
  • Vancouver General Hospital/Vancouver Coastal Health
  • St. Paul's Hospital/Providence Health Care
  • St. Paul's Hospital/Providence Health Care
  • Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB
  • University Health Network
  • CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont
  • Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
  • CHU de Quebec-Universite Laval
  • Fakultni nemocnice Hradec Kralove
  • Vseobecna fakultni nemocnice v Praze
  • Hopital Henri Mondor
  • CHU de Nice - Hopital Pasteur
  • Hopital Necker - Enfants Malades
  • Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie
  • Universitaetsklinikum Aachen
  • Charite - Universitaetsmedizin Berlin
  • Universitaetsklinikum Erlangen
  • Medizinische Hochschule Hannover
  • Uniklinik Koeln
  • Universitaetsklinikum Mannheim
  • Nephrologisches Zentrum Villingen-Schwenningen
  • Sidonia Apotheke
  • Ics Maugeri Spa-Sb Irccs
  • Asst Papa Giovanni Xxiii
  • Nagoya University Hospital
  • Tohoku University Hospital
  • Osaka University Hospital
  • National Hospital Organization Chiba-East Hospital
  • Niigata University Medical & Dental Hospital
  • Hospital Universitario "Dr Jose Eleuterio Gonzalez"
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • SMIQ S de RL de CV
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej
  • Apteka Szpitalna SPZOZ
  • Centrum Zdrowia MDM
  • Miedzyleski Szpital Specjalistyczny w Warszawie
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
  • Univerzitna nemocnica Bratislava
  • Narodny ustav detskych chorob
  • Hospital Público Da Mariña
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic Barcelona
  • Hospital Universitario 12 de Octubre
  • Oxford University Hospitals NHS Foundation Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • University Hospitals Coventry & Warwickshire NHS Trust
  • St. George's University Hospitals NHS Foundation Trust
  • Hammersmith Hospital
  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

PF-06730512 Cohort 1

PF-06730512 Cohort 2

PF-06730512 Cohort 3 (optional)

Arm Description

Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.

Subjects in cohort 2 will receive dose 2 IV infusion.

Subjects in cohort 3 will receive dose 3 IV infusion.

Outcomes

Primary Outcome Measures

Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR).

Secondary Outcome Measures

Percentage change from baseline in UPCR
Percentage change from baseline in estimated glomerular filtration rate (eGFR)
Number of Adverse Events by Severity
Number of subjects with laboratory safety tests (Hematology, Clinical Chemistry, Urinalysis) abnormality
Number of subjects with change in body weight
Number of subjects with increased blood pressure
Number of subjects with increased body temperature
Number of subjects with significant changes in pulse rate
Number of subjects with ECG abnormalities
Serum concentration of PF-06730512
Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb)

Full Information

First Posted
February 22, 2018
Last Updated
July 11, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03448692
Brief Title
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
Acronym
PODO
Official Title
A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to lack of efficacy at both tested doses on 5th December 2022. The decision to terminate the study is not related to a safety concern.
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
February 14, 2023 (Actual)
Study Completion Date
February 14, 2023 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Segmental Glomerulosclerosis (FSGS)
Keywords
Proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06730512 Cohort 1
Arm Type
Experimental
Arm Description
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
Arm Title
PF-06730512 Cohort 2
Arm Type
Experimental
Arm Description
Subjects in cohort 2 will receive dose 2 IV infusion.
Arm Title
PF-06730512 Cohort 3 (optional)
Arm Type
Experimental
Arm Description
Subjects in cohort 3 will receive dose 3 IV infusion.
Intervention Type
Drug
Intervention Name(s)
PF-06730512
Intervention Description
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.
Primary Outcome Measure Information:
Title
Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR).
Time Frame
Baseline to 13 weeks
Secondary Outcome Measure Information:
Title
Percentage change from baseline in UPCR
Time Frame
Baseline to Weeks 3, 5 and 9 and beyond Week 13, as applicable
Title
Percentage change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame
Baseline to Weeks 3, 5, 9, 13 and beyond as applicable
Title
Number of Adverse Events by Severity
Time Frame
Baseline to Day 225
Title
Number of subjects with laboratory safety tests (Hematology, Clinical Chemistry, Urinalysis) abnormality
Time Frame
Baseline to Day 225
Title
Number of subjects with change in body weight
Time Frame
Baseline to Day 225
Title
Number of subjects with increased blood pressure
Time Frame
Baseline to Day 225
Title
Number of subjects with increased body temperature
Time Frame
Baseline to Day 225
Title
Number of subjects with significant changes in pulse rate
Time Frame
Baseline to Day 225
Title
Number of subjects with ECG abnormalities
Time Frame
Baseline to Day 225
Title
Serum concentration of PF-06730512
Time Frame
Day 1 to Day 225
Title
Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb)
Time Frame
Day 1 to Day 225

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS. Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis. Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening. Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment. Exclusion Criteria: Diagnosis of collapsing FSGS. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis. Organ transplant. History of malignancy, with the exception of basal or squamous cell carcinoma that has been treated and fully resolved for a minimum of 5 years. Body mass index (BMI) greater than 45 kg/m2. Subjects with a history of prior treatment with or use of interferon, lithium, pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids, anthracycline (eg, doxorubicin), heroin.
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
The Kirklin Clinic of University Alabama Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Investigational Drug Service Pharmacy UAB Hosptial
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Clinical Research Unit at UAB Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
UAB Nephrology Research Clinic at Paula Building
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Academic Medical Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Ambulatory Infusion Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Cedars-Sinai Comprehensive Transplant Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Clinical and Translational Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Department of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Clinical and Translation Research Unit
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford University-Nephrology Division
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford Health Care Investigational Pharmacy
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University-Nephrology Division
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Yale Center for Clinical Investigation Hospital Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale Nephrology Clinical Research Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Medicine - Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Yale Center for Clinical Investigation - Church Street Research Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
University of Miami Hospital and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Katz Family Division of Nephrology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Georgia Nephrology Research Institute
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Georgia Nephrology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Johnson County Clin Trials
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Boston Medical Center - Interventional Radiology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston Medical Center - Nephrology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston University - GCRU
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Clinical Research Consultants, LLC
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
St. Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
New York University Grossman School of Medicine - CTSI
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
UNC Eastowne
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
UNC Clinical and Translational Research Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7064
Country
United States
Facility Name
University of Cincinnati at DCI McMillan Research Unit
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
Hoxworth Center Subspecialties Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Barrett Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Medical Arts Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Gardner Neuroscience Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Cleveland Clinic - Investigational Drug Pharmacy
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CarePoint East at The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
The Ohio State University Clinical Research Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Kidney and Hypertension Care Center, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Southside Pharmacy
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Prolato Clinical Research Center (PCRC)
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Baylor Scott & White Clinic - Temple South Loop
City
Temple
State/Province
Texas
ZIP/Postal Code
76502
Country
United States
Facility Name
University of Alberta - Pharmacy Research Office
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
University of Alberta - Clinical Investigation Unit
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 287
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Pacific Nephrology Group
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver General Hospital/Vancouver Coastal Health
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
St. Paul's Hospital/Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
St. Paul's Hospital/Providence Health Care
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K8
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
CHU de Quebec-Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Nice - Hopital Pasteur
City
Nice Cedex 1
ZIP/Postal Code
06001
Country
France
Facility Name
Hopital Necker - Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Uniklinik Koeln
City
Koeln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitaetsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Nephrologisches Zentrum Villingen-Schwenningen
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Sidonia Apotheke
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Facility Name
Ics Maugeri Spa-Sb Irccs
City
Pavia PV
State/Province
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Asst Papa Giovanni Xxiii
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
National Hospital Organization Chiba-East Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8510
Country
Japan
Facility Name
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
ZIP/Postal Code
14080
Country
Mexico
Facility Name
SMIQ S de RL de CV
City
Queretaro
ZIP/Postal Code
76070
Country
Mexico
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
Apteka Szpitalna SPZOZ
City
Lodz
ZIP/Postal Code
92-216
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-631
Country
Poland
Facility Name
Miedzyleski Szpital Specjalistyczny w Warszawie
City
Warszawa
ZIP/Postal Code
04-749
Country
Poland
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 01
Country
Slovakia
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava
City
Bratislava
ZIP/Postal Code
831 01
Country
Slovakia
Facility Name
Narodny ustav detskych chorob
City
Bratislava
ZIP/Postal Code
833 40
Country
Slovakia
Facility Name
Hospital Público Da Mariña
City
Burela
State/Province
Lugo
ZIP/Postal Code
27880
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Oxford University Hospitals NHS Foundation Trust
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
University Hospitals Coventry & Warwickshire NHS Trust
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
St. George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
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
Citations:
PubMed Identifier
34169203
Citation
Beck LH Jr, Berasi SP, Copley JB, Gorman D, Levy DI, Lim CN, Henderson JM, Salant DJ, Lu W. PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. Kidney Int Rep. 2021 Apr 3;6(6):1629-1633. doi: 10.1016/j.ekir.2021.03.892. eCollection 2021 Jun.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C0221002
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

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