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NCT00906204 · ClinicalTrials.gov registry record · Phase 2
Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation
A Phase 2 study of End Stage Renal Disease and Kidney Failure, sponsored by Wright State University.
- Completed
- Registry status
- Phase 2
- Development phase
- 99
- Enrollment target
- 4
- Study locations
NCT00906204: Completed Phase 2 study of End Stage Renal Disease and Kidney Failure, sponsored by Wright State University.
NCT00906204 is a Phase 2 study of End Stage Renal Disease and Kidney Failure that has completed, run by Wright State University. The registered enrollment target is 99 participants, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00906204, a Phase 2 study of End Stage Renal Disease and Kidney Failure, has completed, sponsored by Wright State University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 99 participants
- Enrollment target
- 4
- Study locations
Study Summary
In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on 4 days. This new study repeats that dose comparison, but with double-blinding and at multiple transplantation centers.
Primary Outcome
The composite endpoint components and definitions are: * Fever: Body temperature ≥ 38.5˚C. * Hypotension: After rATG initiation, systolic blood pressure ≤ 90 mmHg requiring de novo treatment with vasopressors. * Hypoxia: During transplantation surgery, increase in FiO2 to ≥ 60% following rATG initiation. Following transplantation, starting in recovery room, FiO2 ≥ 50% or nasal cannula delivering ≥ 3 liters, either singly or combined, for \> 12 hours out of a 24 hour period. * Cardiac events: My
Conditions Studied
Interventions
- BIOLOGICAL Single-dose rabbit Anti-thymocyte Globulin induction
- BIOLOGICAL Divided-dose rabbit Anti-thymocyte Globulin induction
Study Locations (4)
Arizona
- University of Arizona - Tucson
Nebraska
- University of Nebraska Medical Center - Omaha
North Carolina
- Wake Forest University - Winston-Salem
Texas
- The Methodist Hospital Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2010-03 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT00906204 record still lists
NCT00906204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 832-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which Single-dose rabbit Anti-thymocyte Globulin induction is the first listed.
NCT00906204 reports a single indexed study location in Arizona, Nebraska, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00906204 about?
NCT00906204 is a clinical study titled "Safety Trial of Single Versus Multiple Dose Thymoglobulin Induction in Kidney Transplantation". In a non-blinded pilot study conducted at the University of Nebraska Medical Center, evidence was found that a single large dose of Thymoglobulin on the day of kidney transplantation produced better kidney function than the standard dosing plan, when the same amount is divided into smaller doses on ...
What is the current status of trial NCT00906204?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 99 participants. The study started on 2010-03. Estimated completion is 2014-07.
What conditions does trial NCT00906204 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Failure.
What interventions are being tested in trial NCT00906204?
The interventions under investigation include: Single-dose rabbit Anti-thymocyte Globulin induction (BIOLOGICAL), Divided-dose rabbit Anti-thymocyte Globulin induction (BIOLOGICAL).
Who is sponsoring clinical trial NCT00906204?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00906204 being conducted?
This trial has 4 study locations across Arizona, Nebraska, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00906204's enrollment target sits among peer trials
99 38th of 86 higher than 49 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease 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.
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