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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 is a Phase 1 study that has completed, run by Kyntra Bio. The registered enrollment target is 20 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00102297
The ClinicalTrials.gov registry entry for NCT00102297 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyntra Bio, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which FG-3019 is the first listed.
NCT00102297 reports 0 study locations.
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.
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