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Study Conducted in China of the Efficacy and Safety of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult De Novo Renal Transplant Patients - Article


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Nafcillin Sodium Injection

Nallpen; Unipen Injection


Clinical Trial: Study Conducted in China of the Efficacy and Safety of Enteric-Coated Mycophenolate Sodium Versus Mycophenolate Mofetil in Adult De Novo Renal Transplant Patients

This study is currently recruiting patients.
Verified by Novartis September 2005

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00149903

Purpose

Purpose of study is to compare the efficacy of enteric-coated mycophenolate sodium compared to mycophenolate mofetil in Chinese patients (study conducted in China) as measured by the incidence of biopsy proven acute rejection, graft loss, or death within six months of treatment in de novo renal transplant patients.
Condition Intervention Phase
Renal transplant
  Drug: Mycophenolate sodium (enteric coated)
 Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Multicenter, Double-Blind, Randomized, Parallel Group Study on Efficacy and Safety of Enteric-Coated Mycophenolate Sodium Vs. Mycophenolate Mofetil in De Novo Chinese Renal Transplant Recipients

Further Study Details: 

Study start: January 2005

Eligibility

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

Inclusion Criteria:

-Recipients of first, cadaveric (with donor written consent form) or living related non-HLA identical donor kidney transplant, treated with cyclosporine and corticosteroids as primary immunosuppression.

Exclusion Criteria:

  • Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ
  • Patients who have received an investigational drug within four weeks prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00149903

Novartis      41 61 324 1111 

China
      General Hospital, Friendship Hospital, Beijing, No 1 Hospital Peking University, Beijing China; Shanghai No 1 Hospital, Shanghai China; Changzheng Hospital, Shanghai, China; Shanghai Ruij, Beijing,  China; Recruiting

Study chairs or principal investigators

Novartis,  Study Director,  Novartis   

More Information

Study ID Numbers:  CERL080A2305
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149903
Health Authority: China: State Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13


Source: ClinicalTrials.gov
Cache Date: September 14, 2005

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Page Updated: June 1, 2005
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