Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2011-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This multicentre, prospective, randomized, open-label study will compare the safety and efficacy of mycophenolate mofetil with delayed introduction of sirolimus and discontinuation of cyclosporine, with those of mycophenolate mofetil and long term continuation of cyclosporine in renal transplant recipients receiving daclizumab (Zenapax) as induction treatment and followed by 8 month treatment with corticosteroids. The anticipated time on study treatment is 12 months. Participants who will complete the initial 12-month study and who will provide written informed consent will be eligible to participate in a 60-month follow-up phase.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Correlation Between Pharmacokinetic and Pharmacodynamic Parameters of CellCept (Mycophenolate Mofetil).

NCT01292226

Kidney Transplantation

COMPLETED PHASE2

A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

NCT00048152

Kidney Transplantation

COMPLETED PHASE3

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

NCT02091414

Heart Transplantation

COMPLETED PHASE3

Study of Therapeutic Monitoring of Mycophenolate Mofetil (MMF/CellCept) After Kidney Transplantation

NCT00087581

Kidney Transplantation

COMPLETED PHASE4

OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

NCT02005562

Kidney Transplantation

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mycophenolate Mofetil + Cyclosporine

Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped.

Daclizumab

Intervention Type DRUG

Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14.

Mycophenoate Mofetil

Intervention Type DRUG

Mycophenoate mofetil 1 gram (g) (2\*500mg tablets or 4\*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.

Prednisolone

Intervention Type DRUG

Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.

Mycophenolate Mofetil + Sirolimus

Participants will receive mycophenoate mofetil, daclizumab, and corticosteroids (prednisolone) for 3 to 12 months. Participants will also receive cyclosporine which will be replaced with sirolimus at later stage of the study.

Group Type EXPERIMENTAL

Cyclosporine

Intervention Type DRUG

Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped.

Daclizumab

Intervention Type DRUG

Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14.

Mycophenoate Mofetil

Intervention Type DRUG

Mycophenoate mofetil 1 gram (g) (2\*500mg tablets or 4\*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.

Prednisolone

Intervention Type DRUG

Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.

Sirolimus

Intervention Type DRUG

Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng/mL from week 12 to week 39, and 5-10 ng/mL from week 39 to week 52.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclosporine

Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped.

Intervention Type DRUG

Daclizumab

Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14.

Intervention Type DRUG

Mycophenoate Mofetil

Mycophenoate mofetil 1 gram (g) (2\*500mg tablets or 4\*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.

Intervention Type DRUG

Prednisolone

Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.

Intervention Type DRUG

Sirolimus

Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng/mL from week 12 to week 39, and 5-10 ng/mL from week 39 to week 52.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Neoral Zenapax CellCept Solupred Rapamycin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Receipt of a first cadaveric kidney graft
* Antilymphocyte antibodies and panel reactive antibodies (PRA) less than 30 percent (%) (historical peak and/or current value)
* Cold ischaemia time less than or equal to 36 hours

Exclusion Criteria

* Kidney from a living donor; donor greater than (\>) 65 years of age; second renal graft, or more; or multiple organ transplant
* Known hypersensitivity to any of the drugs in the study or their components
* History of cancer or malignancy during previous 5 years, other than successfully treated spinocellular or basal cell cancer
* Participant presenting, on inclusion, either symptoms suggestive of active gastroduodenal ulcer, or gastroduodenal ulcer confirmed by fibroscopy and biopsy, and requiring treatment
* Participant with severe refractory hyperlipidaemia
* Pregnant woman or nursing mother

* Episode of acute rejection greater than or equal to grade I (Banff classification)
* Estimated creatinine clearance (CrCl) at week 12 less than (\<) 40 milliliter per minute (mL/min) (Cockcroft-Gault formula)
* Serum creatinine variations \>30% during the 15 days before randomization
* Proteinuria \>1 gram/24 hour, or mean mycophenolate mofetil dose \< 1.5 gram/day during the week before randomization

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No