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COMPLETEDPHASE4

Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

Safety and Tolerability of Enteric-Coated Mycophenolate Sodium in Renal Transplant Patients With GI Intolerance

NCT00150020•Novartis

Summary

The aim of this study is to evaluate the safety and tolerability of EC-MPS in maintenance renal transplant patients who experience gastrointestinal (GI) intolerance due to adverse events associated with mycophenolate mofetil (MMF) and were converted to EC-MPS.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged 18-75 years.
•2. Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
•3. Recipients who are at least 4 weeks post renal transplantation.
•4. Patients currently receiving MMF (all dosages are allowed), cyclosporine microemulsion, its generic equivalent, cyclosporine USP (modified) or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 2 weeks.
•5. Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

Exclusion Criteria

•1. Multi-organ patients (e.g. kidney and pancreas) or previous transplant with any other organ different from kidney (secondary kidney transplant is allowed).
•2. Evidence of graft rejection, treatment of acute rejection or unstable renal function within 4 weeks prior to baseline visit.
•3. Patients who have received an investigational immunosuppressive drug within 4 weeks prior to study entry.

Locations (1)

Novartis

East Hanover, New Jersey, United States

Key Dates

Start Date

October 1, 2004

Primary Completion Date

February 1, 2006

Last Updated

January 24, 2008

Enrollment

728

ESTIMATED participants

Conditions

Renal Transplantation

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)

DRUG

The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation

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Renal Transplantation

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RECRUITINGPHASE2

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

NCT05086003

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ACTIVE_NOT_RECRUITINGPHASE2

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Tolerability of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Patients With GI Intolerance

Inclusion Criteria

Exclusion Criteria

The Effect of Emotion-Focused Intervention on Emotion Regulation and Well-Being of Individuals With Transplantation

Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Mesenchymal Stromal Cells in Living Donor Kidney Transplantation

Tolerance by Engaging Antigen During Cellular Homeostasis

Quantify the Benefits of Biomarkers in Routine Patient Care in Kidney Transplant Recipients

Urinary Biomarkers in Paediatric Kidney Transplantation (pKTx)