Know Cancer

or
forgot password

A Prospective, Comparative, Multicenter, Randomized Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation


Phase 3
18 Years
76 Years
Open (Enrolling)
Both
Kidney Transplantation

Thank you

Trial Information

A Prospective, Comparative, Multicenter, Randomized Study to Compare the Safety and Efficacy of Sirolimus (Rapamune) to Tacrolimus (Advagraf) Associated to Mycophenolate Mofetil (CellCept) Between 12 and 36 Months After Kidney Transplantation


Two doses of Sirolimus will be evaluated accorded to the CYP 3A5 genotype. Patients carrying
at least CYP 3A5 *1 allele will receive 4 mg per day whereas the others (CYP 3A5 *3/*3) will
receive 2 mg.


Inclusion Criteria:



- Recipient age ≥18 and ≤ 75 ans.

- Patients having received a first or second renal transplant from a cadaveric or
living related donor between 12 and 24 months prior the inclusion.

- Peak panel reactive antibody (PRA) < 30 %

- Patients with a stable renal function during the 3 months prior to inclusion
(variation of serum creatinine lower than 20 %)

- Creatinine clearance ≥ 40 ml/mn/1.73 m26.

- Patients receiving as a stable immunosuppressive treatment associating: Mycophenolate
mofétil (MPA AUC > 30 mg.h/L) and Tacrolimus with a trough level > 4 ng/ml, with or
without corticoids

Exclusion Criteria:

- Multi-organ recipients

- Patients receiving cyclosporine

- Pregnancy

- Recipients of ABO incompatible graft

- Use of other immunosuppressive drugs.

- Historical peak reactive antibody ≥ 30 %

- Past medical history of humoral rejection, 2 episodes of acute cellular rejection

- Past medical history of sub-clinical rejection on routine allograft biopsy

- Calculated creatinine clearance < 40 ml/mn/1.73 m2

- 24h proteinuria > 1 g/24H

- Patients with severe diarrhea

- HTLV1 or HIV positivity

- Known hypersensitivity to tacrolimus, mycophénolate mofétil, or sirolimus.

- Total white blood cells < 2500/mm3 or hemoglobine < 9 g/dl

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of a composite endpoint (worsening of GFR estimated with MDRD formula, incidence of cancer and incidence of post-transplant diabetes mellitus) will be assessed 24 months after conversion.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Isabelle ETIENNE, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Rouen

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2007/125/HP

NCT ID:

NCT00811915

Start Date:

December 2008

Completion Date:

June 2014

Related Keywords:

  • Kidney Transplantation
  • Sirolimus
  • Tacrolimus
  • Kidney transplantation
  • Kidney Transplant Recipients

Name

Location