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NCT00556933 · ClinicalTrials.gov registry record · Phase 4
Improved Induction and Maintenance Immunosuppression in Kidney Transplantation
A Phase 4 study of End Stage Renal Disease, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 4
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT00556933 is a Phase 4 study of End Stage Renal Disease that has completed, run by University of Nebraska. The registered enrollment target is 180 participants, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00556933, a Phase 4 study of End Stage Renal Disease, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creating 4 study arms; the other half receive the standard treatment. The two potential improvements are: 1. Administering the immunosuppression induction agent rATG ("rabbit anti-thymocyte globulin") in a single dose at the time of transplantation, instead of in the usual series of 4 smaller doses over 6 days. 2. After 6 months, modifying the maintenance immunosuppression used to prevent rejection by replacing the drug tacrolimus with mycophenolate mofetil (MMF). The two interventions, spaced sequentially six months apart, enable independent analysis of the two treatments so long as it can be shown that there is no synergistic interaction between them.
Conditions Studied
Interventions
- DRUG tacrolimus
- DRUG sirolimus
- DRUG mycophenolate mofetil
- DRUG rabbit anti-thymocyte globulin - single dose
- DRUG rabbit anti-thymocyte globulin - 4 doses
Study Locations (1)
Nebraska
- Unversity of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2004-04-01 |
| Est. Completion | 2011-06-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00556933
The ClinicalTrials.gov registry entry for NCT00556933 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 831-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (78% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with End Stage Renal Disease appearing as the primary indexed condition, and to 5 interventions - of which tacrolimus is the first listed.
NCT00556933 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.
Frequently Asked Questions
What is clinical trial NCT00556933 about?
NCT00556933 is a clinical study titled "Improved Induction and Maintenance Immunosuppression in Kidney Transplantation". This 2 x 2 sequential factorial study evaluates two potential improvements to the standard immunosuppression regimen used at the investigators' institution to prevent rejection of transplanted kidneys. These two potential improvements are each applied in sequence to half of the study patients, creat...
What is the current status of trial NCT00556933?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 180 participants. The study started on 2004-04-01. Estimated completion is 2011-06-01.
What conditions does trial NCT00556933 study?
This clinical trial studies the following conditions: End Stage Renal Disease.
What interventions are being tested in trial NCT00556933?
The interventions under investigation include: tacrolimus (DRUG), sirolimus (DRUG), mycophenolate mofetil (DRUG), rabbit anti-thymocyte globulin - single dose (DRUG), rabbit anti-thymocyte globulin - 4 doses (DRUG).
Who is sponsoring clinical trial NCT00556933?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00556933 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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