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

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Roche

Status and phase

Completed
Phase 3

Conditions

Renal Transplantation

Treatments

Drug: Mycophenoate Mofetil
Drug: Prednisolone
Drug: Daclizumab
Drug: Cyclosporine
Drug: Sirolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT02686619
ML18326

Details and patient eligibility

About

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.

Enrollment

237 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

237 participants in 2 patient groups

Mycophenolate Mofetil + Cyclosporine
Active Comparator group
Description:
Participants will receive mycophenoate mofetil, daclizumab, cyclosporine, and corticosteroids (prednisolone) for 3 to 12 months.
Treatment:
Drug: Cyclosporine
Drug: Daclizumab
Drug: Prednisolone
Drug: Mycophenoate Mofetil
Mycophenolate Mofetil + Sirolimus
Experimental group
Description:
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.
Treatment:
Drug: Sirolimus
Drug: Cyclosporine
Drug: Daclizumab
Drug: Prednisolone
Drug: Mycophenoate Mofetil

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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