Trials / Completed

CompletedNCT00102297

Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

A Phase 1 Study of the Safety, Pharmacokinetics, and Biologic Activity of Escalating Doses of FG-3019 in Subjects With Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus

Status: Completed
Phase: Phase 1
Study type: Interventional
Enrollment: 20 (estimated)

Sponsor: Kyntra Bio · Industry
Sex: All
Age: 21 Years – 80 Years
Healthy volunteers: Not accepted

Summary

The Phase 1b study is a multi-center trial designed to test the safety, tolerability, biologic activity of escalating doses of FG-3019 in up to 20 patients with type 1 or type 2 diabetes and microalbuminuria (early-stage kidney disease). Patients will receive either 3 or 10 mg/kg of FG-3019 administered every two weeks as an infusion for a total of four doses. The ability of FG-3019 to reduce the excretion of protein in the urine is being measured as a secondary endpoint.

Conditions

Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	FG-3019

Timeline

Start date: 2005-01-01
Completion: 2007-06-01
First posted: 2005-01-27
Last updated: 2007-12-12

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00102297. Inclusion in this directory is not an endorsement.