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Completed

NCT Number: NCT00171392

Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.

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Key information

Conditions

Prevention of Acute Rejection After Kidney Transplantation

Age range

18 year and older

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

  • First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
  • Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion criteria

Subjects expected to discontinue tacrolimus therapy;

  • Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline;
  • Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

Treatment and study plan

Enteric-Coated Mycophenolate Sodium

Drug

Primary outcomes

  1. Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula

Secondary outcomes

  1. Incidence of biopsy proven acute rejection

  2. Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)

  3. Quality of life related to GI symptoms (GIQLI scale)

  4. Full blood count

  5. Gastrointestinal Adverse Events (check-list)

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Sep 15, 2005
Registry last updated
Feb 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.

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