Clinical trial NCT02686619: 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
Official title: Multicentre, Prospective, Randomized, Open-label Study Comparing the Efficacy and Safety of CellCept With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Standard Immunosuppression Comprising CellCept and Long-term Continuation of Cyclosporine in Renal Transplant Recipients Receiving Induction by Zenapax and Treated With Corticosteroids for 8 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-02-19
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Exclusion Criteria for Follow-up Phase:

* 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

Primary outcomes:
measure: Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Month 60
timeFrame: 60 months
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to approximately 12 months
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From 12 months up to 60 months
measure: Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Week 52
timeFrame: 52 weeks
measure: Number of Participants With Cancers and Lymphoproliferative Syndromes
timeFrame: Up to approximately 12 months
measure: Number of Participants With Premature Discontinuations due to Adverse Events (AEs)
timeFrame: Up to approximately 12 months
measure: Change From Baseline in 24-Hour Urinary Protein at Week 52
timeFrame: 52 weeks
Secondary outcomes:
measure: Mean Inverse Creatinine Concentration
timeFrame: Week 4, 8, 12, 14, 16, 26, 39, and 52
measure: Creatinine Clearance Calculated and Corrected According to Cockcroft-Gault
timeFrame: Week 4, 8, 12, 14, 16, 26, 39, and 52
measure: Glomerular Filtration Rate (GFR) Measured by Iohexol Clearance
timeFrame: Baseline, Week 52
measure: Number of Participants with Response to Treatment, Defined as Creatinine Clearance >/=60 mL/min at Week 52
timeFrame: Week 52
measure: Number of Participants With Treated Rejections
timeFrame: Baseline up to Week 52
measure: Mean Serum Creatinine Concentration
timeFrame: Week 4, 8, 12, 14, 16, 26, 39, and 52
measure: Number of Participants With Biopsy-proven Acute Rejections
timeFrame: Baseline up to Month 60
measure: Number of Participants With Histologic Evaluation of the Graft
timeFrame: Week 52
measure: Number of Participants Who Were Alive
timeFrame: Month 60
measure: Number of Participants With Graft Survival
timeFrame: Month 60
Other outcomes:
Locations:
city: Angers
country: France
city: Caen
country: France
city: Clermont-ferrand
country: France
city: La Tronche
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lyon
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Poitiers
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rouen
country: France
city: Salouel
country: France
city: Strasbourg
country: France
city: Tours
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: