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OpenTrials
Completed

NCT Number: NCT00238992

Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.

All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.

The purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.

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Key information

Conditions

Kidney de Novo Transplant

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients undergoing first kidney transplant.
  • Patients aged 18 -70 years.
  • Patients receiving an ABO identical or compatible graft. Exclusion Criteria
  • Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.
  • Positive HBsAg test
  • Pre-Transplant PRA >50% or historical PRA >75% Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. biopsy proven acute rejection incidence at 1 year post-transplantation

Secondary outcomes

  1. Incidence of biopsy proven acute rejection episodes at 6 months

  2. Incidence of treated rejection episodes at 6 months and 1 year

  3. Incidence of steroid-resistant episodes at 6 months and 1 year

  4. Patient and graft survival at 1 year

  5. Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)

  6. Percentage of patients free from steroids at 6 months and 1 year

  7. Treatment safety

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.

Important dates

Study start
2002
Primary completion
2005
First posted
Oct 14, 2005
Registry last updated
Nov 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.