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

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ClinicalTrials.gov Identifier: NCT03448692
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 22, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date April 22, 2021
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date February 5, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR). [ Time Frame: Baseline to 13 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2020)
  • Percentage change from baseline in UPCR [ Time Frame: Baseline to Weeks 3, 5 and 9 ]
  • Number of partial remission events of proteinuria [ Time Frame: Week 13 ]
  • Number of complete remission events of proteinuria [ Time Frame: Week 13 ]
  • Percentage change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Weeks 3, 5, 9 and 13 ]
  • Number of Adverse Events by Severity [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with laboratory safety tests (Hematology, Clinical Chemistry, Urinalysis) abnormality [ Time Frame: Baseline to 13 weeks ]
  • Number of subjects with change in body weight [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with increased blood pressure [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with increased body temperature [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with significant changes in pulse rate [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with ECG abnormalities [ Time Frame: Baseline to Day 141 ]
  • Serum concentration of PF-06730512 [ Time Frame: Day 1 to Day 141 ]
  • Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb) [ Time Frame: Day 1 to Day 141 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Number of Adverse Events by Severity [ Time Frame: Baseline to Day 148 ]
  • Number of subjects with laboratory safety abnormality [ Time Frame: Baseline to 12 weeks ]
  • Number of subjects with increased body weight [ Time Frame: Baseline to Day 148 ]
  • Number of subjects with increased blood pressure [ Time Frame: Baseline to Day 148 ]
  • Number of subjects with increased body temperature [ Time Frame: Baseline to Day 148 ]
  • Number of subjects with significant changes in pulse rate [ Time Frame: Baseline to Day 148 ]
  • Percentage change from baseline in UPCR [ Time Frame: Baseline to Weeks 3, 5, 9, and 12 ]
  • Number of partial remission events of proteinuria [ Time Frame: Week 13 ]
  • Percentage change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Weeks 3, 5, 9, 12 and 13 ]
  • Serum concentration of PF-06730512 [ Time Frame: Day 1 to Day 148 ]
  • Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb) [ Time Frame: Day 1 to Day 148 ]
  • Number of complete remission events of proteinuria [ Time Frame: Week 13 ]
  • Number of subjects with ECG abnormalities [ Time Frame: Baseline to Day 148 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
Official Title  ICMJE A PHASE 2, 12 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)
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 infusion in adult subjects with FSGS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Open label
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis (FSGS)
Intervention  ICMJE Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.
Study Arms  ICMJE
  • Experimental: PF-06730512 Cohort 1
    Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
    Intervention: Drug: PF-06730512
  • Experimental: PF-06730512 Cohort 2
    Subjects in cohort 2 will receive dose 2 IV infusion.
    Intervention: Drug: PF-06730512
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 5, 2024
Estimated Primary Completion Date February 5, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults age 18 years and older who have a confirmed 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. Body mass index (BMI) greater than 45 kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Canada,   Czechia,   Germany,   Italy,   Japan,   Poland,   Slovakia,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448692
Other Study ID Numbers  ICMJE C0221002
2019-003607-35 ( EudraCT Number )
PODO ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP