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

NCT ID: NCT01601821

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 245 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-03-31

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.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (CsA+Rapamune+CS)

Group Type: ACTIVE_COMPARATOR

CsA+Rapamune+CS

Intervention Type: DRUG

Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months

Arm B (CsA+MMF+CS)

Group Type: EXPERIMENTAL

CsA+MMF+CS

Intervention Type: DRUG

The control arm is the standard local practice (official protocol) in Iran:

Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.

Interventions

CsA+Rapamune+CS

Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months

Intervention Type: DRUG

CsA+MMF+CS

The control arm is the standard local practice (official protocol) in Iran:

Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.

Intervention Type: DRUG

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Labbafinejad Hospital

Tehran, , Iran

Modarres Hospital

Tehran, , Iran

Shariati Hospital

Tehran, , Iran

Taleqani Hospital

Tehran, , Iran

Countries

Iran

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0468H-102012

To obtain contact information for a study center near you, click here.

Other Identifiers

B1741220

Identifier Type: -

Identifier Source: secondary_id

0468H-102012

Identifier Type: -

Identifier Source: org_study_id