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Completed Phase 1 Interventional

Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

ClinicalTrials.gov ID: NCT00754143

Public ClinicalTrials.gov record NCT00754143. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study of Safety, Pharmacokinetics and Pharmacodynamics of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy on Background ACEi and/or ARB Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.

Study identification

NCT ID
NCT00754143
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Kyntra Bio
Industry
Enrollment
38 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2008
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009
Last update posted
Aug 1, 2019

2008 – 2009

United States locations

U.S. sites
18
U.S. states
14
U.S. cities
18
Facility City State ZIP Site status
Not listed Birmingham Alabama
Not listed Tempe Arizona
Not listed La Mesa California
Not listed Torrance California
Not listed Kissimmee Florida
Not listed Atlanta Georgia
Not listed Springfield Massachusetts
Not listed Omaha Nebraska
Not listed Flushing New York
Not listed New York New York
Not listed Chapel Hill North Carolina
Not listed Cleveland Ohio
Not listed Portland Oregon
Not listed Hershey Pennsylvania
Not listed Dallas Texas
Not listed Houston Texas
Not listed San Antonio Texas
Not listed Fairfax Virginia

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00754143, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 1, 2019 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00754143 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →