Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients

Tracking Information
First Submitted Date ICMJE	October 12, 2005
First Posted Date ICMJE	October 14, 2005
Last Update Posted Date	February 23, 2017
Study Start Date ICMJE	January 2005
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 31, 2006)	patient and graft survival; acute rejection incidence; graft function; safety
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00239083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 31, 2006)	influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients
Official Title ICMJE	Phase IV Study of Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Kidney Transplant Patients
Brief Summary	The aim of MYFORMS is to assess efficacy and safety on clinical outcomes of EC-MPS in combination with Cyclosporine microemulsion (CsA-ME) in kidney transplant recipients.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Kidney Transplantation
Intervention ICMJE	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Study Arms	Experimental: EC-MPS; Intervention: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Publications *	Nart A, Sipahi S, Aykas A, Uslu A, Hoşcoşkun C, Toz H. Efficacy and safety of enteric-coated mycophenolate sodium in de novo and maintenance renal transplant patients. Transplant Proc. 2008 Jan-Feb;40(1):189-92. doi: 10.1016/j.transproceed.2007.11.066.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: May 31, 2006)	40
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	August 2006
Actual Primary Completion Date	August 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	De Novo-Inclusion criteria; Males and females aged 6 years or over.; Recipients of cadaveric, living unrelated or living related kidney transplant, treated with CsA-Me, with or without corticosteroids, as primary immunosuppression. Maintenance-Inclusion criteria; Males and females aged 6 years or over.; Recipients of first or secondary cadaveric, living related or unrelated donor kidney transplant.; Patients currently receiving CsA-ME with or without Mycophenolate mofetil (MMF) or azathioprine, with or without corticosteroids as part of their immunosuppressive regimen for at least 3 months prior to Screening.; Patients in a stable condition in terms of graft function (serum creatinine not above 2.3 mg/dL (=204 µmol/L) at screening and at baseline, or not increased by more than 20% at baseline compared to values obtained at screening), no change of immune suppressive regimen due to graft malfunction, and any known clinically significant physical and/or laboratory changes for at least 2 months prior to enrollment. De Novo and Maintenance-Exclusion Criteria; Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.; Patients with any known hypersensitivity to MPA, EC-MPS or other components of the formulation (e.g. lactose).; Patients with thrombocytopenia (< 75,000/mm3), with an absolute neutrophil count of < 1,500/mm3, and/or leukocytopenia (< 2,500/mm3), and/or hemoglobin < 6 g/dL at Screening or Baseline.; Patients with a history of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin. Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender	Sexes Eligible for Study: All
Ages	6 Years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers	Not Provided
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Switzerland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00239083
Other Study ID Numbers ICMJE	CERL080ATR01
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Novartis
Study Sponsor ICMJE	Novartis
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Novartis Novartis
PRS Account	Novartis
Verification Date	February 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP