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PODO - 0221002

University of North Carolina at Chapel Hill


Description

The purpose of this research study is to learn about the overall safety, tolerability (how well patients can tolerate) and effects on kidney markers of the study drug (PF-06730512). We will also measure drug levels to see how much drug is in participants' blood (pharmacokinetics), following intravenous administration every two weeks over 12 weeks. Intravenous administration means that the study drug is infused into one of the veins on your arm. The primary goal of this study is to obtain an early sign that the drug works (improves markers of kidney health).


Keywords:

Kidneys


Category:

Drug or Biologic
Phase:2

Qualifications

 


Age
18 - 70 years


Gender
Any


Study Population

Adults with a kidney disease called FSGS, not yet on or close to dialysis, not transplanted.


Investigator

Amy Mottl
Clinical Associate Professor
Medicine-Nephrology

For questions, contact:

Anne Froment
anne_froment@med.unc.edu
(919) 445-2622
Visit Website

Recruitment Period End

December 31, 2021

Location

Primary Location
Clinical and Translational Research Center (CTRC)
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 70 years

Participant qualification(s) leaking protein in the urine, having already been treated with one or two drugs.

Not eligible if: having received a new kidney, being on dialysis

Number of Visits

    » 15 In person visit(s)

    12 weeks of screening; 12 weeks of treatment (one infusion every other week) and 4 weeks of follow-up

    » 7 Remote visit(s)

    phone calls

Participation Period

8 months

Compensation

small compensation, gas mileage, parking coupons

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.