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NCT00102297 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus
A Phase 1 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00102297: Completed Phase 1 study, sponsored by Kyntra Bio.
NCT00102297 is a Phase 1 study that has completed, run by Kyntra Bio. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00102297, a Phase 1 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study 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.
Interventions
- DRUG FG-3019
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-01 |
| Est. Completion | 2007-06 |
| Phase | Phase 1 |
What the finished NCT00102297 record still lists
NCT00102297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which FG-3019 is the first listed.
NCT00102297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00102297 about?
NCT00102297 is a clinical study titled "Study of the Safety of FG-3019 in Incipient Nephropathy Due to Type 1 or Type 2 Diabetes Mellitus". 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 administ...
What is the current status of trial NCT00102297?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-01. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00102297?
The interventions under investigation include: FG-3019 (DRUG).
Who is sponsoring clinical trial NCT00102297?
This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00102297's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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