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NCT Number: 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

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.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cyclosporine

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.

Other names: Neoral

Daclizumab

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.

Other names: Zenapax

Mycophenoate Mofetil

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.

Other names: CellCept

Prednisolone

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.

Other names: Solupred

sirolimus

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.

Other names: Rapamycin

Primary outcomes

  1. Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Month 60

    Time frame: 60 months

  2. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to approximately 12 months

  3. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: From 12 months up to 60 months

  4. Creatinine Clearance Calculated and Corrected According to Cockcroft Gault at Week 52

    Time frame: 52 weeks

  5. Number of Participants With Cancers and Lymphoproliferative Syndromes

    Time frame: Up to approximately 12 months

  6. Number of Participants With Premature Discontinuations due to Adverse Events (AEs)

    Time frame: Up to approximately 12 months

  7. Change From Baseline in 24-Hour Urinary Protein at Week 52

    Time frame: 52 weeks

Secondary outcomes

  1. Mean Inverse Creatinine Concentration

    Time frame: Week 4, 8, 12, 14, 16, 26, 39, and 52

  2. Creatinine Clearance Calculated and Corrected According to Cockcroft-Gault

    Time frame: Week 4, 8, 12, 14, 16, 26, 39, and 52

  3. Glomerular Filtration Rate (GFR) Measured by Iohexol Clearance

    Time frame: Baseline, Week 52

  4. Number of Participants with Response to Treatment, Defined as Creatinine Clearance >/=60 mL/min at Week 52

    Time frame: Week 52

  5. Number of Participants With Treated Rejections

    Time frame: Baseline up to Week 52

  6. Mean Serum Creatinine Concentration

    Time frame: Week 4, 8, 12, 14, 16, 26, 39, and 52

  7. Number of Participants With Biopsy-proven Acute Rejections

    Time frame: Baseline up to Month 60

  8. Number of Participants With Histologic Evaluation of the Graft

    Time frame: Week 52

  9. Number of Participants Who Were Alive

    Time frame: Month 60

  10. Number of Participants With Graft Survival

    Time frame: Month 60

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Feb 19, 2016
Registry last updated
Feb 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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