Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids

Pfizer

Status and phase

Completed

Phase 4

Conditions

Inflammation

Treatments

Drug: CsA+MMF+CS

Drug: CsA+Rapamune+CS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01601821

B1741220

0468H-102012

Details and patient eligibility

About

To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.

Enrollment

245 patients

Sex

All

Ages

13 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 13 years and weight 40 kg
End-stage renal disease, with patients receiving a primary or secondary renal allograft from a living-unrelated donor, or from a living-related donor.
Women who are of childbearing potential must have a negative pregnancy test before enrollment in the study and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation from the study.
Total white blood cell count 4.0 x 109/L (4,000/mmP3P), platelet count 100 x 10P9P/L(100,000/mmP3P), fasting triglycerides ≤ 4.6 mmol/L (400 mg/dL), fasting cholesterol ≤ 7.8 mmol/L (300 mg/dL). If it is not possible to obtain fasting triglycerides and cholesterol before surgery, historical values (within 1 year) may be used.
Signed and dated informed consent (parent or legal guardian must provide consent for patients <18 years of age). An assent form will be signed by patients < 18 years of age enrolled in the study.

Exclusion criteria

Evidence of active systemic or localized major infection at the time of initial Sirolimus administration.
Cadaveric donors
History of malignancy within 5 years before enrollment into the study (with the exception of adequately treated basal cell or squamous cell carcinoma of the skin)
Use of any investigational drug other than specified in the protocol during the 4 weeks before enrolling in the study.
Use of planned antibody induction therapy at the time of transplantation.
Active gastrointestinal disorder that may interfere with drug absorption.
Known hypersensitivity to Sirolimus, MMF or Cyclosporine or its derivatives.
Multiple organ transplants (2 or more organ transplant e.g. Kidney and Pancreas).
Patient with high risk of rejection (eg. Patients with a PRA >50%, black patients and patients with 2nd transplant who lost their first graft within the first 6 months).
Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening