NCT00400647

Brief Summary

This study will assess the quality of life in renal transplant recipients who require a reduced dose of mycophenolate mofetil (MMF) because of gastrointestinal (GI) side effects and will also access the relationship between mycophenolic acid (MPA) dose in those patients receiving enteric-coated mycophenolate sodium formulation(EC-MPS). Patients will be evaluated at baseline, 2 weeks after study medicine conversion and then again at 12 weeks post-conversion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2006

Typical duration 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

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

2.2 years

First QC Date

November 16, 2006

Last Update Submit

February 3, 2017

Conditions

Maintenance Kidney Transplant

Keywords

kidney transplantenteric-coated mycophenolate sodiumquality of lifegastrointestinal symptoms

Outcome Measures

Primary Outcomes (1)

  • To determine the effect of the use of EC-MPS on the quality of life of patients requiring MMF dose reduction due to gastrointestinal symptoms

    12 weeks

Secondary Outcomes (2)

  • To determine whether EC-MPS enables the administration of higher doses with good tolerability, compared with standard MMF treatment, in patients with shown susceptibility to undesirable GI effects

    12 weeks

  • To measure health-related quality of life (HRQOL) through the GI quality of life index (GIQLI) and the psychological general well-being index (PGWB)

    12 weeks

Study Arms (2)

EC MPS

EXPERIMENTAL

Up to 1440mg taken in two doses

Drug: Enteric-coated Mycophenolate sodium (EC-MPS)

Mycophenolate mofetil

ACTIVE COMPARATOR

250 mg or 500 mg in two equal doses

Drug: Mycophenolate mofetil

Interventions

Enteric-coated Mycophenolate sodium (EC-MPS)DRUG
EC MPS
Mycophenolate mofetilDRUG
Mycophenolate mofetil

Eligibility Criteria

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

You may qualify if:

  • Patients who are recipients of a renal transplant.
  • Patients treated with an immunosuppressive regiment including MMF before recruitment.
  • Patients suffering from GI side effects related to MMF standard doses or patients treated with a reduced MMF dose to control the aforementioned GI side effects.
  • Patients 18 years or older.
  • Patients who have given written informed consent to participate in the study
  • Patients complying with all study requirements including completing questionnaires and attending to the three study visits.

You may not qualify if:

  • Patients with GI symptoms assumed or known not to be caused by MPA therapy (eg. oral bisphosphonate induced, infectious diarrhea)
  • Acute rejection less than 1 week before recruitment.
  • Females of childbearing potential who are pregnant, planning to get pregnant and/or breast feeding or not willing to practice an approved method of birth control.
  • Presence of psychiatric disorder, such as schizophrenia or major depression, in the investigator's opinion, could interfere with study requirements.
  • Patients undergoing surgery due to acute illness or hospitalized.
  • Existence of any medical condition which, in the investigator's opinion based on anamnesis or medical records, could affect study completion, including but not limiting visual problems or cognitive deterioration.
  • Patients currently treated or who have been treated with any other study drug or treatment within 30 days prior to baseline visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • Ortega F, Sanchez-Fructuoso A, Cruzado JM, Gomez-Alamillo JC, Alarcon A, Pallardo L, Morales JM, Oliver J, Guinea G; MYVIDA Study Group. Gastrointestinal quality of life improvement of renal transplant recipients converted from mycophenolate mofetil to enteric-coated mycophenolate sodium drugs or agents: mycophenolate mofetil and enteric-coated mycophenolate sodium. Transplantation. 2011 Aug 27;92(4):426-32. doi: 10.1097/TP.0b013e31822527ca.

    PMID: 21760569RESULT

MeSH Terms

Interventions

Mycophenolic Acid

Intervention Hierarchy (Ancestors)

CaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty AcidsLipids

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

CH(1)