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Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

Last updated on November 14, 2019

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Study Location
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Focal Segmental Glomerulosclerosis (FSGS)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Adults age between 18 and 65 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT03448692
Pfizer
Not yet recruiting
Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis

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Descriptive Information
Brief Title  ICMJE A Study 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 SummaryThe 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.
Detailed DescriptionNot 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 15, 2021
Estimated Primary Completion DateMarch 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Adults age 18 years and older who has a confirmed diagnosis of primary 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.

Exclusion Criteria:

  1. Diagnosis of secondary and/or collapsing FSGS.
  2. Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  3. Body mass index (BMI) greater than 40 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 Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03448692
Other Study ID Numbers  ICMJE C0221002
POPD ( Other Identifier: Alias Study Number )
PODO ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNot 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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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