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NCT00005113 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant
A Phase 3 study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT00005113: Clinical Trial Phase 3 study, sponsored by Boston Children's Hospital.
NCT00005113 is a Phase 3 study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 102 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00005113, a Phase 3 study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received kidney transplants. SRL is a new medication that may prevent the body's immune system from rejecting organ transplants. After receiving a kidney transplant, the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney. This can lead to rejection of the new kidney and a failed transplant. To help reduce the risk of kidney rejection, transplant patients are given immunosuppressant drugs, which reduce the body's normal immune response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that are often given to transplant patients. However, these are powerful drugs, and it can cause serious side effects and put a patient at increased risk for infections. SRL is a new drug that has been shown to reduce a transplant patient's chance of rejecting a new kidney, without serious side effects. This study is necessary to test the safety and effectiveness of SRL in children.
Interventions
- DRUG Sirolimus
- DRUG Tacrolimus
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 1999-07 |
| Est. Completion | 2006-03 |
| Phase | Phase 3 |
Why NCT00005113 stopped before completion
NCT00005113 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Sirolimus is the first listed.
NCT00005113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00005113 about?
NCT00005113 is a clinical study titled "A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant". The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received kidney transplants. SRL is a new medication that may prevent the body's immune system from rejecting organ transplants...
What is the current status of trial NCT00005113?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 1999-07. Estimated completion is 2006-03.
What interventions are being tested in trial NCT00005113?
The interventions under investigation include: Sirolimus (DRUG), Tacrolimus (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00005113?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00005113's enrollment target sits among peer trials
102 1676th of 2000 higher than 321 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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