Clinical trial NCT00369278: Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
Official title: Multi-center, Open-label, Prospective, Randomized, Parallel Group Study Investigating an Intensified Enteric-coated Mycophenolate Sodium (EC-MPS) Dosing Regimen in Comparison to a Standard Dosing Regimen of EC-MPS in Combination With Cyclosporin Microemulsion and Corticosteroids in de Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Renal transplantation, mycophenolate
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the association of an initially intensified dosing regimen of enteric-coated mycophenolate sodium (EC-MPS) during the first 6 weeks post renal transplantation with acute rejections relative to the rapid achievement of an MPA (mycophenolic acid) exposure of ≥ 40 mg\*h/L compared to a standard dosing regimen of EC-MPS. Additionally, this study will assess safety and tolerability of the intensified dosing regimen of EC-MPS. This study will be conducted in 2 stages (Stage I and Stage II).


Eligibility criteria: Inclusion criteria

1. Recipients of de novo cadaveric, living unrelated or living related kidney transplants
2. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at baseline, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility.
3. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

1. More than one previous renal transplantation
2. Graft loss due to immunological reasons in the first year after transplantation (in case of secondary transplantation)
3. Multi-organ recipients (e.g., kidney and pancreas) or previous transplant with any other organ, different from kidney
4. Patients receiving a kidney from a non-heart beating donor
5. Patients who are recipients of A-B-O incompatible transplants

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L
timeFrame: Assessed on day 3, 10, 21, 42, 56 and 84
measure: Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment
timeFrame: 6 months
measure: Number of Participants With Any Treatment Failure
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants With Single Treatment Failures
timeFrame: 6 months
measure: Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180
timeFrame: 6 months
measure: Time to "Event" for the Composite Endpoint as Well as All Individual Components of That Endpoint "Treatment Failure" Including Clinical Rejections
timeFrame: 6 months
measure: Renal Function as Measured by Serum Creatinine
timeFrame: 6 months
measure: Renal Function as Measured by Glomerular Filtration Rate (GFR)
timeFrame: 6 months
Other outcomes:
Locations:
city: Various Cities
country: Germany
facility: Novartis Investigational Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: