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Trial record 1 of 1 for:    NCT03448692
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Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

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ClinicalTrials.gov Identifier: NCT03448692
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : June 4, 2019
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 June 4, 2019
Actual Study Start Date  ICMJE October 15, 2018
Estimated Primary Completion Date March 16, 2021   (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 Complete list of historical versions of study NCT03448692 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2018)
  • Number of Adverse Events by Severity [ Time Frame: Baseline to Day 141 ]
  • Number of subjects with laboratory safety abnormality [ Time Frame: Baseline to 13 weeks ]
  • Number of subjects with increased 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 ]
  • 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 ]
  • Percentage change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Weeks 3, 5, 9 and 13 ]
  • 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 ]
  • Number of complete remission events of proteinuria [ Time Frame: Week 13 ]
  • Number of subjects with ECG abnormalities [ Time Frame: Baseline 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 Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis
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 PRIMARY 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 primary FSGS. In addition, the intention is to obtain an early indication of efficacy. This study may have two doses in two separate cohorts, and it will be conducted in 2 phases: an optional longitudinal observational Natural History Phase (Part A) and an adaptive Treatment Phase (Part B).
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 March 16, 2021
Estimated Primary Completion Date March 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults age between 18 and 70 years who has a confirmed diagnosis of primary FSGS.
  2. Glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2 based on the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) formula, with a single repeat measurement permitted, as appropriate.
  3. UPCR greater than 1.5 g protein/g creatinine at screening.

Exclusion Criteria:

  1. Diagnosis of secondary and/or collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulo interstitial fibrosis.
  3. Obesity (based on estimated dry weight at onset of disease prior to steroid therapy, if applicable) defined as body mass index (BMI) greater than 40 kg/m2.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (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,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448692
Other Study ID Numbers  ICMJE C0221002
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 May 2019

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