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OpenTrials
Completed

NCT Number: NCT00238940

Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 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/ Exclusion criteria

  • All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium (EC-MPS)

Drug

Primary outcomes

  1. Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.

Secondary outcomes

  1. Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.

  2. Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation

  3. Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup

  4. Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.

  5. Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 14, 2005
Registry last updated
Jan 31, 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.

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