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

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ClinicalTrials.gov Identifier: NCT00284934
Recruitment Status : Completed
First Posted : February 1, 2006
Results First Posted : May 2, 2011
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Diseases Drug: Enteric-coated mycophenolate sodium (EC-MPS) Drug: Tacrolimus Drug: Corticosteroids Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, National, Open-label, Prospective, Randomized Study to Evaluate Efficacy and Tolerability of Enteric-coated Mycophenolate Sodium 1440 mg/Day With Tacrolimus Reduced Dose Versus Enteric-coated Mycophenolate Sodium 720 mg/Day With Tacrolimus Standard Dose, in Maintenance, Stable, Adult, Kidney Transplant Recipients
Study Start Date : December 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard dose EC-MPS
Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) adjusted to maintain the trough blood level (C0) contained between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
 Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Other Name: Myfortic

Drug: Tacrolimus
Other Name: Prograf

Drug: Corticosteroids
At a dose of at least 5 mg/day.
Other Name: Prednisone
Experimental: High EC-MPS
Patients received 1440 mg/day (720 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus dose (twice a day orally) tapered to reach a trough blood level target contained between 2 and 4.5 ng/mL within 15 days after randomization at the most. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center's standard practice, but at a dose of at least 5 mg/day.
 Drug: Enteric-coated mycophenolate sodium (EC-MPS)
Other Name: Myfortic

Drug: Tacrolimus
Other Name: Prograf

Drug: Corticosteroids
At a dose of at least 5 mg/day.
Other Name: Prednisone


Outcome Measures
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Primary Outcome Measures :
  1. Renal Function Assessed by Change in Estimated Glomerular Filtration Rate(eGFR) [ Time Frame: Baseline and Month 6 ]
    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.


Secondary Outcome Measures :
  1. Renal Function at 3 Months Assessed by Change in Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Baseline and 3 months ]
    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.

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

  3. Number of Participants With Graft and Patient Survivals at 6 Months [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284934


Locations
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Switzerland
Novartis
Basel, Switzerland
Sponsors and Collaborators
Novartis
Investigators
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Study Director: Novartis Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00284934    
Other Study ID Numbers: CERL080AFR04
First Posted: February 1, 2006    Key Record Dates
Results First Posted: May 2, 2011
Last Update Posted: May 2, 2011
Last Verified: March 2011
Keywords provided by Novartis:
Dose optimization
immune suppressive regimen
enteric-coated mycophenolate sodium
EC-MPS
renal transplantation
 kidney
transplant
maintenance patients
Renal transplantation in maintenance
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Mycophenolic Acid
Prednisone
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents