Study Details

Open

Testing new drug (PODO - 0221002) for patients with FSGS

This research study will test a new drug (called PF-06730512), designed to improve indicators of kidney health in patients with FSGS. We want to learn about the drug's safety, how patients tolerate it, how it impacts markers of kidney health, and if it does what it's designed to do.

Age & Gender

1 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Orange)

What will be asked of you

To be sure you are a good fit for the study, there will be 3 visits over the first 8 weeks. The treatment period lasts for another 12 weeks. During this time, every participant will receive the study drug (one of two doses) through an IV in the arm every 2 weeks (total of 6 times). There is no placebo in this study. After each IV dose, we will measure the amount of the drug in your blood over the course of a few hours - this helps us to know how your body is working to process it. There is then a follow-up period which involves 4 visits over 2.5 months. Visits over the course of the study will include blood and urine collection, vital sign measurements, physical exam, electrocardiogram (EKG), questionnaires, demographic questions and review of medications. Some visits will require that you fast (don't eat for an amount of time) beforehand.

Incentives

Compensation provided - contact the study team for more information, A standard travel reimbursement is provided for each study visit.

In-person visits:
22

Phone or online visits:
11

Total length of participation:
11 months

Looking for Specific Volunteers

Able to participate:

A kidney biopsy has shown you have Focal Segmental GlomeruloSclerosis (FSGS)
You have protein in your urine
Kidney function measurement: eGFR needs to be greater than or equal to 45 ml/min/1.73m2. If you don't know this, we can measure it

Not eligible if:

On dialysis
On the transplant list
Type 1 Diabetes
Type 2 Diabetes not well controlled (HgA1C >8%)
Recent treatment with rituximab (within the last 6 months)

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

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

Additional Study Information

Principal Investigator

Amy Mottl
Medicine-Nephrology

Study Type

Clinical or Medical
Interventional

Study Topics

Kidneys and Liver

IRB Number

18-2513

ClinicalTrials.gov

NCT03448692