MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00284921
First received: January 30, 2006
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.


Condition Intervention Phase
De Novo Kidney Transplant
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Hepatic function tests (ALT/AST) after 12 months treatment.

Secondary Outcome Measures:
  • Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
  • Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
  • Glomerular filtration rate and by proteinuria after 12 months treatment.
  • Graft survival after 12 months.
  • Incidence of AEs and SAEs after 3 and 12 months.
  • Blood pressure, lipids and glucose profiles after 3 and 12 months.
  • Percentage of patients free of steroids at 12 months between the two investigational groups.
  • Viral load (HCV RNA) between both groups at 12 months.
  • Bone density at 12 months in both groups.

Estimated Enrollment: 60
Study Start Date: April 2004
Primary Completion Date: August 2006 (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

  1. Patients hepatitis C positive (serology test within the last 12 months and determined by third-generation assay).
  2. Recipients of heart-beating cadaveric, living unrelated or living related non-HLA identical donor kidney transplant, treated with basiliximab and CsA-ME as primary immunosuppression.

Exclusion criteria

  1. Multi-organ recipients (e.g. double kidney, kidney and pancreas or kidney and liver) or previous transplant with any other organ.
  2. Kidneys from non-heart beating donors.
  3. ABO incompatibility against the donor.
  4. Patients with panel reactive antibodies of >50% at most recent assessment prior to transplantation and /or prior graft lost due to immunological reasons in the first six months post-transplantation or patients who are considered to be at increased risk of acute rejection by the principal investigator Additional 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: NCT00284921

Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00284921     History of Changes
Other Study ID Numbers: CERL080AES02
Study First Received: January 30, 2006
Last Updated: November 1, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
kidney transplant, hepatitis C, enteric-coated mycophenolate sodium

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Basiliximab
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 July 26, 2014