Clinical Trial: A One-Year, Open Label Study to Investigate the Safety and the Effect of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Combination with Cyclosporine Microemulsion in De Novo Kidney Transplant Recipients.

This study is no longer recruiting patients.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00154245

Purpose

The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a 12-month open-label treatment period on EC-MPS.
Condition Intervention Phase
Kidney Transplantation
 Drug: Enteric-Coated Mycophenolate sodium (EC-MPS)
Phase IV

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further Study Details: 

Study start: November 2003

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Males and females aged 18-75 years.
  • Recipients of de novo cadaveric, living unrelated or living related kidney transplants

Exclusion Criteria:

  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ.
  • Patients who are recipients of A-B-O incompatible transplants.
  • Patients with a historical or current peak PRA of  50%.
  • Patients with already existing antibodies against the HLA-type of the receiving transplant.
  • Evidence of severe liver disease (incl. abnormal liver profile i.e. AST, ALT or total bilirubin  3 times UNL).
  • Patients who are HIV or Hepatitis B surface antigen positive.
  • Patients with any known hypersensitivity to mycophenolic acid, MMF, EC-MPS, 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Location Information

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  CERL080ATW01
Last Updated:  September 9, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00154245
Health Authority: Taiwan: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13

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