Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients

Novartis94 enrolled

Overview

This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to prevent the progression of chronic allograft nephropathy, while maintaining the same efficacy, in maintenance renal transplant recipients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Diseases

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)DRUG

TacrolimusDRUG

CorticosteroidsDRUG

At a dose of at least 5 mg/day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Primary or secondary kidney transplant * Treatment with mycophenolic acid (MMF 1 g/d or EC-MPS 720 mg/d) and tacrolimus (trough concentration \[C0\] ≥ 5.5 ng/mL) * Creatinine clearance ≥ 30 mL/min and \< 60 mL/min and stable renal function Exclusion Criteria: * Multi-organ recipients or previous transplant with any other organ different from kidney * Biopsy proven acute rejection or treated acute rejection within the last 3 months. * Prescription of mycophenolate mofetil 1 g/d or mycophenolate sodium 720 mg/d due to adverse event occurrence when higher doses were administered Other protocol-defined inclusion/exclusion criteria may apply.

Locations (1)

Novartis

Basel, Switzerland

Outcomes

Primary Outcomes

Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR)

Change in estimated glomerular filtration rate from baseline to Month 6 calculated by using abbreviated Modification of Diet in Renal Disease (MDRD) formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where -C is the serum concentration of creatinine \[mg/dL\], -A is patient age at sample collection date \[years\], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.

Time frame: Baseline and Month 6

Secondary Outcomes

Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR)

Change in estimated glomerular filtration rate from baseline to Month 3 calculated by using abbreviated MDRD formula. Modification of Diet in Renal Disease (MDRD) formula is: GFR \[mL/min/1.73m\^2\] = 186.3\*(C\^-1.154)\*(A\^-0.203)\*G\*R where -C is the serum concentration of creatinine \[mg/dL\], -A is patient age at sample collection date \[years\], -G=0.742 when gender is female, otherwise G=1, -R=1.21 when race is black, otherwise R=1.

Time frame: Baseline and 3 months

Number of Participants With Treatment Failure Parameters (Biopsy-Proven Acute Rejection (BPAR), Graft Loss, Death, or Loss to Follow-up) at 6 Months

A biopsy-proven acute rejection (BPAR) is defined as a biopsy graded IA, IB, IIA, IIB, or III based on the Banff 1997 classification.The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss.

Time frame: 6 months

Number of Participants With Graft and Patient Survivals at 6 Months

Graft survival was defined as the number of patients with no graft loss. The allograft was presumed lost on the day the patient started dialysis and was not able to subsequently be removed from dialysis. If the patient went through a graft nephrectomy, then the day of nephrectomy was the day of graft loss. Patient survival was defined as the number of patients alive with or without a functioning graft.

Data from ClinicalTrials.gov

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