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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03448692
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Focal Segmental Glomerulosclerosis (FSGS) Drug: PF-06730512 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : May 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: PF-06730512 Cohort 1
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
 Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.
Experimental: PF-06730512 Cohort 2
Subjects in cohort 2 will receive dose 2 IV infusion.
 Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR). [ Time Frame: Baseline to 13 weeks ]

Secondary Outcome Measures :
  1. Percentage change from baseline in UPCR [ Time Frame: Baseline to Weeks 3, 5 and 9 ]
  2. Number of partial remission events of proteinuria [ Time Frame: Week 13 ]
  3. Number of complete remission events of proteinuria [ Time Frame: Week 13 ]
  4. Percentage change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Weeks 3, 5, 9 and 13 ]
  5. Number of Adverse Events by Severity [ Time Frame: Baseline to Day 141 ]
  6. Number of subjects with laboratory safety tests (Hematology, Clinical Chemistry, Urinalysis) abnormality [ Time Frame: Baseline to 13 weeks ]
  7. Number of subjects with change in body weight [ Time Frame: Baseline to Day 141 ]
  8. Number of subjects with increased blood pressure [ Time Frame: Baseline to Day 141 ]
  9. Number of subjects with increased body temperature [ Time Frame: Baseline to Day 141 ]
  10. Number of subjects with significant changes in pulse rate [ Time Frame: Baseline to Day 141 ]
  11. Number of subjects with ECG abnormalities [ Time Frame: Baseline to Day 141 ]
  12. Serum concentration of PF-06730512 [ Time Frame: Day 1 to Day 141 ]
  13. Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb) [ Time Frame: Day 1 to Day 141 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03448692


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03448692    
Other Study ID Numbers: C0221002
2019-003607-35 ( EudraCT Number )
PODO ( Other Identifier: Alias Study Number )
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Proteinuria
Additional relevant MeSH terms:
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Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases