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NCT00064701 · ClinicalTrials.gov registry record · Phase 3
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
A Phase 3 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 668
- Enrollment target
NCT00064701: Completed Phase 3 study, sponsored by Astellas Pharma.
NCT00064701 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 668 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00064701, a Phase 3 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 668 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
Primary Outcome
Efficacy failure is defined as any participant who died, experienced a graft failure (permanent return to dialysis \[\> 30 days\] or retransplant), had a biopsy-confirmed (Banff Grade ≥ I) acute rejection (BCAR), or was lost to follow-up. Biopsies were graded according to the 1997 Banff criteria: Borderline: No intimal arteritis present but foci of mild tubulitis; Grade I: Significant interstitial infiltration and foci of moderate to severe tubulitis; Grade II: Mild to severe intimal arteritis
Interventions
- DRUG Tacrolimus
- DRUG mycophenolate mofetil
- DRUG Tacrolimus Modified Release (MR)
- DRUG cyclosporine microemulsion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 668 participants |
| Start Date | 2003-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00064701 record still lists
NCT00064701 is an interventional study that assigns participants to a tested intervention. The registered 668 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 (13% lower).
The record links to 0 conditions, and to 4 interventions - of which Tacrolimus is the first listed.
NCT00064701 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00064701 about?
NCT00064701 is a clinical study titled "Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients". The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.
What is the current status of trial NCT00064701?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 668 participants. The study started on 2003-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00064701?
The interventions under investigation include: Tacrolimus (DRUG), mycophenolate mofetil (DRUG), Tacrolimus Modified Release (MR) (DRUG), cyclosporine microemulsion (DRUG).
Who is sponsoring clinical trial NCT00064701?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00064701's enrollment target sits among peer trials
668 548th of 2000 higher than 1,450 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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