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

NCT01601821 | Completed Phase 4 Results

• 2 other identifiers: 0468H-102012B1741220
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Efficacy Failure

  Efficacy failure was defined as first occurrence of either biopsy confirmed acute rejection, graft loss or death within 12 months of post-transplantation. Percentage of participants with efficacy failure was reported.

  Baseline up to Month 12

Secondary Outcomes (12)

• Serum Creatinine Level

  Month 3, 6, 12

• Creatinine Clearance

  Month 3, 6, 12

• Glomerular Filtration Rate (GFR) by Nankivell Method

  Month 3, 6, 12

• Incidence of Biopsy-Confirmed Acute Rejection

  Baseline up to Month 6

• Histologic Grade of First Acute Rejection

  Baseline up to Month 12

Study Arms (2)

Arm A (CsA+Rapamune+CS)

ACTIVE COMPARATOR

Drug: CsA+Rapamune+CS

Arm B (CsA+MMF+CS)

EXPERIMENTAL

Drug: CsA+MMF+CS

Interventions

CsA+Rapamune+CS 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 A (CsA+Rapamune+CS)

CsA+MMF+CS 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.

Arm B (CsA+MMF+CS)

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Labbafinejad Hospital

Tehran, Iran

Location

Modarres Hospital

Tehran, Iran

Location

Shariati Hospital

Tehran, Iran

Location

Taleqani Hospital

Tehran, Iran

Location

Related Links

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

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 12, 2018
• Results First Posted: June 19, 2013

Record last verified: 2018-11

Locations

IR (4)