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

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Colorado Kidney Care
Denver, Colorado, 80218 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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

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Trial To Evaluate PF-06730512 In Adults With Primary Focal Segmental Glomerulosclerosis
An Adaptive, Phase 2 Trial To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-06730512 Following Multiple Injections In Adult Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)
The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple injections 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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
Double Blinded study

Primary Purpose: Treatment

Focal Segmental Glomerulosclerosis (FSGS)
Drug: PF-06730512
Subcutaneous injection given once a week for 12 weeks. The dose for each cohort is to be determined (TBD) based on emerging data
  • Experimental: PF-06730512 Cohort 1
    1 dose every week for 12 weeks
    Intervention: Drug: PF-06730512
  • Experimental: PF-06730512 Cohort 2
    1 dose every week for 12 weeks
    Intervention: Drug: PF-06730512
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
44
December 19, 2020
December 19, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  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:

  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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03448692
C0221002
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2018

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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