Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00537862
First received: October 1, 2007
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

This study will evaluate the efficacy and safety of enteric-coated mycophenolate sodium (EC-MPS) in a cyclosporine microemulsion based regimen with C2 monitoring in de novo kidney transplant recipients


Condition Intervention Phase
Kidney Transplant
Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients ; A Prospective, Open Label, Multi-center Study

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Efficacy & safety of enteric-coated mycophenolate sodium combined with cyclosporine microemulsion & corticosteroids assessed by overall survival at 6 months, biopsy proven acute rejection, graft loss, adverse events and serious adverse events.

Secondary Outcome Measures:
  • Tolerability of full dose of EC-MPS assessed by dose reduction & treatment discontinuation rates due to adverse events

Enrollment: 200
Study Start Date: May 2006
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Korean Males and females aged 18 to 65 years.
  • Recipients of first, living unrelated or living related non-HLA identical donor kidney
  • Transplant, treated with cyclosporine microemulsion (Cs-ME) as primary immunosuppressant.
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization. Effective contraception must be used during the trial and for 6 weeks following discontinuation of the study medication but at least for four months after randomization, even where there has been a history of infertility.

Exclusion Criteria:

  • Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any other organ.
  • Kidneys from cadaveric donors or HLA identical living related donors.
  • Patients with any known hypersensitivity to enteric coated Mycophenolate sodium (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 (<4,000/mm3 ), or hemoglobin < 6g/dL .
  • Patients who have received any investigational drug within 30 days prior to study entry.
  • Patients with a history of malignancy within the last five years, except for successfully excised squamous or basal cell carcinoma of the skin.
  • Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating, who are unwilling to use effective means of contraception.
  • Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication, and/or presence of severe diarrhea, active peptic ulcer disease, or uncontrolled diabetes mellitus.
  • Patients with clinically significant infection requiring continued therapy.
  • Known positive HIV status.
  • Positive HBsAg test, or Hepatitis C positive with advanced liver disease or with clinical or pathological diagnosis of cirrhosis.
  • Evidence of drug and/or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537862

Locations
Korea, Republic of
Novartis Investigative Site
Busan, Korea, Republic of, (614-735)
Novartis Investigative Site
Daegu, Korea, Republic of, (700-712)
Novartis Investigative Site
Daegu, Korea, Republic of, (700-721)
Novartis Investigative Site
Jeollanam-do, Korea, Republic of, (501-757)
Novartis Investigative Site
Seoul, Korea, Republic of, (110-744)
Novartis Investigative Site
Seoul, Korea, Republic of, (120-752)
Novartis Investigative Site
Seoul, Korea, Republic of, (138-736)
Novartis Investigative Site
Seoul, Korea, Republic of, (137-701)
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00537862     History of Changes
Other Study ID Numbers: CERL080AKR02
Study First Received: October 1, 2007
Last Updated: November 1, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Novartis:
Kidney Transplant Patients
Immunosuppresion
Enteric-coated mycophenolate sodium

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 19, 2014