Study 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.
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
PODO
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)
4 other identifiers
interventional
47
12 countries
110
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2018
Typical duration for phase_2
110 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2023
CompletedResults Posted
Study results publicly available
April 18, 2024
CompletedApril 18, 2024
April 1, 2024
4.3 years
February 22, 2018
February 1, 2024
April 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
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.
Baseline, Week 13
Secondary Outcomes (11)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
Number of Participants With Abnormalities in Laboratory Test Parameters
From Day 1 of treatment up to Week 33
Change From Baseline in Body Weight
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change From Baseline in Blood Pressure
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
Change From Baseline in Pulse Rate
Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33
- +6 more secondary outcomes
Study Arms (3)
PF-06730512 Cohort 1
EXPERIMENTALSubjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
PF-06730512 Cohort 2
EXPERIMENTALSubjects in cohort 2 will receive dose 2 IV infusion.
PF-06730512 Cohort 3 (optional)
EXPERIMENTALSubjects in cohort 3 will receive dose 3 IV infusion.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (110)
The Kirklin Clinic of University Alabama Birmingham Hospital
Birmingham, Alabama, 35233, United States
Investigational Drug Service Pharmacy UAB Hosptial
Birmingham, Alabama, 35249, United States
Clinical Research Unit at UAB Hospital
Birmingham, Alabama, 35294, United States
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, 35294, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Cedars-Sinai Ambulatory Infusion Center
Los Angeles, California, 90048, United States
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, 90048, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Clinical and Translational Research Center
Los Angeles, California, 90095, United States
UCLA Department of Medicine
Los Angeles, California, 90095, United States
Clinical and Translation Research Unit
Palo Alto, California, 94304, United States
Stanford University-Nephrology Division
Palo Alto, California, 94304, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford Health Care Investigational Pharmacy
Stanford, California, 94305, United States
Stanford University-Nephrology Division
Stanford, California, 94305, United States
Stanford University
Stanford, California, 94305, United States
Yale Center for Clinical Investigation Hospital Research Unit
New Haven, Connecticut, 06510, United States
Yale Nephrology Clinical Research Clinic
New Haven, Connecticut, 06510, United States
Yale University School of Medicine - Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University
New Haven, Connecticut, 06510, United States
Yale New Haven Hospital
New Haven, Connecticut, 06511, United States
Yale Center for Clinical Investigation - Church Street Research Unit
New Haven, Connecticut, 06519, United States
University of Miami Hospital and Clinics
Miami, Florida, 33136, United States
University of Miami Katz Family Division of Nephrology
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
Georgia Nephrology Research Institute
Lawrenceville, Georgia, 30046, United States
Georgia Nephrology
Lawrenceville, Georgia, 30046, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Johnson County Clin Trials
Lenexa, Kansas, 66219, United States
Boston Medical Center - Interventional Radiology
Boston, Massachusetts, 02118, United States
Boston Medical Center - Nephrology
Boston, Massachusetts, 02118, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston University - GCRU
Boston, Massachusetts, 02118, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Clinical Research Consultants, LLC
Kansas City, Missouri, 64111, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
New York University Grossman School of Medicine - CTSI
New York, New York, 10016, United States
UNC Eastowne
Chapel Hill, North Carolina, 27514, United States
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, 27599-7064, United States
University of Cincinnati at DCI McMillan Research Unit
Cincinnati, Ohio, 45206, United States
Hoxworth Center Subspecialties Clinic
Cincinnati, Ohio, 45219, United States
UC Health Barrett Center
Cincinnati, Ohio, 45219, United States
UC Health Medical Arts Building
Cincinnati, Ohio, 45219, United States
University of Cincinnati Gardner Neuroscience Institute
Cincinnati, Ohio, 45229, United States
The Cleveland Clinic - Investigational Drug Pharmacy
Cleveland, Ohio, 44195, United States
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
CarePoint East at The Ohio State University
Columbus, Ohio, 43203, United States
The Ohio State University Clinical Research Center
Columbus, Ohio, 43210, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43210, United States
The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit
Columbus, Ohio, 43210, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Kidney and Hypertension Care Center, PA
Houston, Texas, 77004, United States
Southside Pharmacy
Houston, Texas, 77030, United States
Prolato Clinical Research Center (PCRC)
Houston, Texas, 77054, United States
Baylor Scott & White Clinic - Temple South Loop
Temple, Texas, 76502, United States
University of Alberta - Pharmacy Research Office
Edmonton, Alberta, T6G 1Z1, Canada
University of Alberta - Clinical Investigation Unit
Edmonton, Alberta, T6G 287, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Pacific Nephrology Group
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver General Hospital/Vancouver Coastal Health
Vancouver, British Columbia, V5Z 1M9, Canada
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia, V6Z 1Y6, Canada
St. Paul's Hospital/Providence Health Care
Vancouver, British Columbia, V6Z 2K8, Canada
Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB
Toronto, Ontario, M4G 3E8, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
Centre for Innovative Medicine, Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec-Universite Laval
Québec, G1R 2J6, Canada
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Hopital Henri Mondor
Créteil, 94010, France
CHU de Nice - Hopital Pasteur
Nice, 06001, France
Hopital Necker - Enfants Malades
Paris, 75015, France
Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Aachen
Aachen, 52074, Germany
Charite - Universitaetsmedizin Berlin
Berlin, 10117, Germany
Uniklinik Koeln
Cologne, 50937, Germany
Universitaetsklinikum Erlangen
Erlangen, 91054, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen, 78052, Germany
Sidonia Apotheke
Villingen-Schwenningen, 78052, Germany
Ics Maugeri Spa-Sb Irccs
Pavia PV, Pavia, 27100, Italy
Asst Papa Giovanni Xxiii
Bergamo, 24127, Italy
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8560, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
National Hospital Organization Chiba-East Hospital
Chiba, 260-8712, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8510, Japan
Hospital Universitario "Dr Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
SMIQ S de RL de CV
Querétaro, 76070, Mexico
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Lodz, 92-213, Poland
Apteka Szpitalna SPZOZ
Lodz, 92-216, Poland
Centrum Zdrowia MDM
Warsaw, 00-631, Poland
Miedzyleski Szpital Specjalistyczny w Warszawie
Warsaw, 04-749, Poland
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, 975 01, Slovakia
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Univerzitna nemocnica Bratislava
Bratislava, 831 01, Slovakia
Narodny ustav detskych chorob
Bratislava, 833 40, Slovakia
Hospital Público Da Mariña
Burela de Cabo, LUGO, 27880, Spain
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic Barcelona
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Oxford University Hospitals NHS Foundation Trust
Headington, Oxford, OX3 7LE, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, CV2 2DX, United Kingdom
St. George's University Hospitals NHS Foundation Trust
London, SW17 0QT, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB, United Kingdom
Related Publications (1)
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.
PMID: 34169203DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2018
First Posted
February 28, 2018
Study Start
October 15, 2018
Primary Completion
February 14, 2023
Study Completion
February 14, 2023
Last Updated
April 18, 2024
Results First Posted
April 18, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
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.