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OpenTrials
Completed

NCT Number: NCT00369278

Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients

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).

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Key information

Conditions

Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigational Site

Various Cities, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recipients of de novo cadaveric, living unrelated or living related kidney transplants
  • 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.
  • Patients who are willing and able to participate in the study and from whom written informed consent has been obtained.

Exclusion criteria

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

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Tablets for oral administration

Other names: myfortic

Primary outcomes

  1. Time to First Occurrence of a Mycophenolic Acid (MPA) Plasma Concentration of ≥ 40 mg*h/L

    Time frame: Assessed on day 3, 10, 21, 42, 56 and 84

    Non-compartmental MPA pharmacokinetic parameters were derived from individual plasma concentration-time profiles using WinNonLin 5.2 software. The areas under the curve were calculated by means of the linear trapezoidal rule.

  2. Time to First Occurrence of Any Treatment Failure During the First 6 Months Post-treatment or at Month 6 Post-treatment

    Time frame: 6 months

    Median time to first occurrence of treatment failure was not reached in this study.

  3. Number of Participants With Any Treatment Failure

    Time frame: 6 months

    Treatment failures were defined as a composite endpoint of biopsy proven acute rejection (BPAR), graft loss, and death, loss to follow up and discontinuations from study drug treatment due to lack of efficacy or toxicity (at least one condition must be present) during the first 6 months or until final assessment. Any participants who were suspected of having acute rejection episodes had biopsies performed to prove whether a rejection had occurred. Graft loss was considered as the day the patient started dialysis and was not able to subsequently be removed or the day of graft nephrectomy.

Secondary outcomes

  1. Number of Participants With Single Treatment Failures

    Time frame: 6 months

    Rates for all individual components of the primary endpoint 'treatment failure' until day 180:

    • Acute rejection diagnosed by biopsy (BPAR)
    • graft loss
    • death
    • loss to follow up
    • discontinuation from study drug due to lack of efficacy or toxicity (adverse events, every adverse event had to be interpreted as toxicity)
    • conversion to another dosing regimen (conversion to tacrolimus, prograf, etc.)

  2. Rates of Events for Treated Acute Rejection, Death, Graft Loss, or Loss to Follow up on Day 28, Day 84, and Day 180

    Time frame: 6 months

    Due to a small number of events, median time to <event> was not reached.

  3. Time to "Event" for the Composite Endpoint as Well as All Individual Components of That Endpoint "Treatment Failure" Including Clinical Rejections

    Time frame: 6 months

    Due to a small number of events, median time to <event> was not reached.

  4. Renal Function as Measured by Serum Creatinine

    Time frame: 6 months

  5. Renal Function as Measured by Glomerular Filtration Rate (GFR)

    Time frame: 6 months

    The Glomerular Filtration Rate (GFR) was calculated using the following formulas:

    • Cockcroft-Gault formula: calculation using the participant's age, gender, weight, and serum creatinine levels.
    • MDRD formula: calculation using the participant's age, gender, serum creatinine, urea nitrogen, and albumin levels.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 29, 2006
Registry last updated
Mar 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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