Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Micoemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00369278

Purpose

This study 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).

Condition	Intervention	Phase
Renal Transplantation	Drug: Enteric-coated mycophenolate sodium (EC-MPS) Drug: myfortic with sandimmune	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Cyclosporin Cyclosporine Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Mycophenolate sodium Corticosteroids Mycophenolic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Micoemulsion and Corticosteroids in de Novo Renal Transplant Patients

Further study details as provided by Novartis:

Primary Outcome Measures:

Stage I:
MPA exposure at different time points after transplantation
Time to achieve an MPA exposure of ≥ 40 mg*h/mL on day 3, day 10, day 21, day 42, day 56, and day 84
Stage II:
Time to occurrence of treatment failure during the first 6 months post-treatment or at month 6 post-treatment

Secondary Outcome Measures:

Stage I:
Safety and tolerability of EC-MPS during the study
Incidence of acute rejection and graft loss during the study
Pharmacokinetic profile of EC-MPS by determination of MPA metabolites and the free fraction of MPA on day 3, day 10, day 21, day 42, day 56, and day 84
IMPDH (inosine monophosphate dehydrogenase) activity and pharmacokinetic-pharmaco-dynamic relationship at baseline, day 3, day 10, day 21, and day 56
Stage II:
Occurrence of treatment failures at day 28 and day 84
Rates of events for treated acute rejection, death, graft loss, or loss to follow up on day 28, day 84, and day 180
All individual components of the composite endpoint "treatment failure", including the assessment of the rate of clinical rejections
Time to "event" for the composite endpoint as well as all individual components of that endpoint "treatment failure" including clinical rejections
Renal function as measured by serum creatinine and glomerular filtration rate on day 3, day 10, day 14, day 21, day 42, day 56, day 84, and at the end of study

Estimated Enrollment:	120
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2008

Arms	Assigned Interventions
1: Experimental	Drug: Enteric-coated mycophenolate sodium (EC-MPS) experimental
2: Active Comparator	Drug: myfortic with sandimmune active comparator

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369278

Contacts

Contact: novartis

41613241111

Locations

Germany
Novartis Investigational Site	Recruiting
Various Cities, Germany
Contact: novartis 41 61 324 1111

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis

More Information

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CERL080ADE12
Study First Received:	August 25, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00369278
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Renal transplantation, mycophenolate

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole

Mycophenolate mofetil
Mycophenolic Acid
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Antifungal Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009