Clinical trial NCT01601821: Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids
Official title: An Open Label Comparative Study Of De Novo Renal Allograft Recipients Receiving CSA + MMF + Corticosteroids Versus CSA + Rapamune + Corticosteroids With Further CSA Elimination In The Rapamune Arm With The Introduction Of MMF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-18
Enrollment: 245
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Efficacy Failure
timeFrame: Baseline up to Month 12
Secondary outcomes:
measure: Serum Creatinine Level
timeFrame: Month 3, 6, 12
measure: Creatinine Clearance
timeFrame: Month 3, 6, 12
measure: Glomerular Filtration Rate (GFR) by Nankivell Method
timeFrame: Month 3, 6, 12
measure: Incidence of Biopsy-Confirmed Acute Rejection
timeFrame: Baseline up to Month 6
measure: Histologic Grade of First Acute Rejection
timeFrame: Baseline up to Month 12
measure: Percentage of Participants Who Survived
timeFrame: Month 12
measure: Percentage of Participants With Graft Survival
timeFrame: Month 12
measure: Incidence of Presumptive or Documented Infection
timeFrame: Baseline up to Month 12
measure: Incidence of Histologically Confirmed Lymphoproliferative Disease
timeFrame: Baseline up to Month 12
measure: Percentage of Participants With Efficacy Failure or Premature Elimination
timeFrame: Month 12
measure: Incidence of Anemia
timeFrame: Baseline up to Month 12
measure: Number of Participants Who Discontinued
timeFrame: Month 12
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinejad Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Modarres Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Taleqani Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: