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

Pfizer245 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

245

Conditions

Inflammation

Interventions

CsA+Rapamune+CSDRUG

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

CsA+MMF+CSDRUG

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.

Eligibility

Sex: ALLMin age: 13 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

Labbafinejad Hospital

Tehran, Iran

Modarres Hospital

Tehran, Iran

Shariati Hospital

Tehran, Iran

Taleqani Hospital

Tehran, Iran

Outcomes

Primary Outcomes

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.

Time frame: Baseline up to Month 12

Secondary Outcomes

Serum Creatinine Level

Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatine, commonly found in blood, urine and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 milligram per deciliter (mg/dL) for females and 0.6 to 1.2 mg/dL for males; however, the normal values are age-dependent as elderly patients typically have smaller muscle mass.

Time frame: Month 3, 6, 12

Creatinine Clearance

Creatinine clearance (CCr) is a measure of kidney function. CCr is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 millimeters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

Time frame: Month 3, 6, 12

Glomerular Filtration Rate (GFR) by Nankivell Method

GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR was calculated using the Nankivell formula. GFR by Nankivell equation= (6.7 per serum creatinine) plus (0.25\*body weight) minus (0.5\*serum urea) minus (100 per height square) plus (35 for male or 25 for female). A normal GFR is greater than (\>)90 mL/min per 1.73 m\^2 \[mL/min/1.73 m\^2\], although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR less than (\<)15 mL/min/1.73 m\^2 indicated kidney failure.

Data from ClinicalTrials.gov

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