NCT00150020

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
728

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

Enrollment Period

1.3 years

First QC Date

September 6, 2005

Last Update Submit

January 21, 2008

Conditions

Renal Transplantation

Keywords

Renal/KidneyTransplantationMPAEC-MPSRenal Transplantation Patients with GI Intolerance with MMF

Outcome Measures

Primary Outcomes (1)

  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS) after conversion from MMF in maintenance renal transplant patients with GI intolerance

    within 3 months

Secondary Outcomes (4)

  • Safety of EC-MPS in combination with CsA-ME or tacrolimus as determined by incidence and severity of GI adverse events

    within 3 months

  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus as determined by gastrointestinal symptom rating scale (GSRS)

    within 1 month

  • Efficacy of EC-MPS in combination with CsA-ME or tacrolimus as measured by the incidence of biopsy-proven acute rejection

    within 3 months

  • Tolerability of EC-MPS in combination with CsA-ME or tacrolimus by comparing the two study groups

    after 3 months

Interventions

Enteric-coated mycophenolate sodium (EC-MPS)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18-75 years.
  • Recipients of first or secondary cadaveric, living unrelated or living related kidney transplant.
  • Recipients who are at least 4 weeks post renal transplantation.
  • 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.
  • Patients with mild and/or moderate GI complaints (e.g. upper abdominal pain, dyspepsia, anorexia, nausea, vomiting) with or without diarrhea.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, United States

Location

Related Publications (1)

  • Bolin P, Tanriover B, Zibari GB, Lynn ML, Pirsch JD, Chan L, Cooper M, Langone AJ, Tomlanovich SJ. Improvement in 3-month patient-reported gastrointestinal symptoms after conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in renal transplant patients. Transplantation. 2007 Dec 15;84(11):1443-51. doi: 10.1097/01.tp.0000290678.06523.95.

    PMID: 18091520DERIVED

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2006

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations

US(1)