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

NCT00239083 | Completed Phase 4

• 1 other identifier: CERL080ATR01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation

Keywords

MYFORMS, Kidney Transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS), Cyclosporine microemulsion (CsA-ME)

Outcome Measures

Primary Outcomes (4)

• patient and graft survival

• acute rejection incidence

• graft function

• safety

Secondary Outcomes (1)

• influence of demographic characteristics, transplant-related variables, medical conditions and post-transplantation complications on the main clinical outcomes, according to the immunosuppressive regimen used.

Study Arms (1)

EC-MPS

EXPERIMENTAL

Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

Interventions

Enteric-Coated Mycophenolate Sodium (EC-MPS) DRUG

EC-MPS

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

• Nart A, Sipahi S, Aykas A, Uslu A, Hoscoskun 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.

  PMID: 18261583 RESULT

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 14, 2005
• Study Start: January 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CH (1)