Renal TransplantPhase 4NCT00239005

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in people with Renal Transplant, run by Novartis Pharmaceuticals at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This open, multi-center randomized controlled study is designed to investigate the quality of life in patients with mycophenolate mofetil (MMF)-induced gastrointestinal (GI) adverse events after converting to enteric-coated mycophenolate sodium (EC-MPS). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Transplant
What is being tested?: Enteric-Coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2005to Mar 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Received kidney transplant
Receiving immunosuppressive regimen that includes MMF
Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
At least 18 years of age
Willing to provide written informed consent
Able to meet all study requirements including completing questionnaires and completing four study visits.

Who cannot join

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization
Any other medical condition that, in the opinion of the site investigator based on recall or chart review, would interfere with completing the study, including, but not limited to, visual problems or cognitive impairment.
Receiving any investigational drug or have received any investigational drug within 30 days prior to study enrollment.
Additional protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Novartis Investigative Site
Nottingham

Other trials in United Kingdom

About this study

Official title: A Study of the Effect of Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS) on Quality of Life in Patients With Gastrointestinal (GI) Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation (MYQOL)

Conditions: Renal Transplant
Being tested: Enteric-Coated Mycophenolate Sodium (EC-MPS), Mycophenolate Mofetil (MMF)
Keywords: QoL, GI Side Effects, MPA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enteric-Coated Mycophenolate Sodium (EC-MPS)Drug
Also called Myfortic®
Mycophenolate Mofetil (MMF)Drug
Also called Cellcept®

Study groups in NCT00239005
Study group	Role	What they receive
Mycophenolate Mofetil (MMF)	Active comparator	250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening. Receives: Drug: Mycophenolate Mofetil (MMF)
Enteric-Coated Mycophenolate Sodium (EC-MPS )	Experimental	Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening. Receives: Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Mycophenolic Acid (MPA) Maintenance Treatment
The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.
Measured: at week 13 (last visit)

Secondary outcomes (2)

Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).
The GSRS is a 15-item instrument designed to assess the impact of upper and lower GI symptoms. There are five subscales: reflux, diarrhea, constipation, abdominal pain, and indigestion-each of which produces a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort). A higher score represents greater impairment of quality of life due to GI symptoms (range from 1 to 7).
Measured: At week 3 and week 13 (last visit)
Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).
Health-related quality of life (HRQoL)was assessed by the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a 36-item questionnaire to assess the impact of GI disease on daily life. The GIQLI also has five different subscales (GI symptoms, emotional status, physical and social functions, and stress of medical treatment) producing a total score of the 36 items. Lower scores represent more dysfunction. A higher score represents a better quality of life (range from 0 to 144).
Measured: At week 3 and week 13 (last visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Mar 2008

First posted14 Oct 2005 (estimated)
Study startSep 2005
Primary completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal TransplantStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00239005
Sponsor's protocol ID: CERL080AGB03
Other IDs: 2004-005071-42, 2004
Status last verified: Feb 2017
First submitted: 12 Oct 2005
Last updated: 30 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney

All Renal Transplant trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Effect of Conversion to Enteric-Coated Mycophenolate Sodium (EC-MPS) on Quality of Life in Patients With Gastrointestinal (GI) Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation (MYQOL)
ClinicalTrials.gov ID: NCT00239005
Acronym / sponsor ID: CERL080AGB03
Conditions: Renal Transplant
Keywords: QoL, GI Side Effects, MPA
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Mar 2008 (actual)
First posted: 14 Oct 2005 (estimated)
Results: Posted 24 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mycophenolate Mofetil (MMF)	Active comparator	Drug: Mycophenolate Mofetil (MMF)250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
Enteric-Coated Mycophenolate Sodium (EC-MPS )	Experimental	Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Received kidney transplant
Receiving immunosuppressive regimen that includes MMF
Patients with GI side effects on standard MMF doses or patients on reduced dose MMF with existing but tolerated/controlled GI side effects.
At least 18 years of age
Willing to provide written informed consent

Key exclusion criteria (8 listed)

Patients with GI symptoms assumed or known not to be caused by medroxyprogesterone acetate (MPA) therapy (e.g. oral bisphosphonate induced, infectious diarrhea)
Acute rejection < 1 week prior to study enrollment
Woman of child-bearing potential who is planning to become pregnant or is pregnant and/or lactating and who is unwilling to use effective means of contraception
Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements
Undergoing acute medical intervention or hospitalization

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enteric-Coated Mycophenolate Sodium (EC-MPS)Also: Myfortic®	Drug	Enteric-Coated Mycophenolate Sodium (EC-MPS )
Mycophenolate Mofetil (MMF)Also: Cellcept®	Drug	Mycophenolate Mofetil (MMF)

Primary outcome

Mycophenolic Acid (MPA) Maintenance Treatment
Time frame: at week 13 (last visit)
The primary assessment was based on the percentage of patients who were maintained at week 13 on a dose at least one dose equivalent greater than at baseline (visit 2/week 1). A dose equivalent was defined as EC-MPS 180 mg/day or MMF 250 mg/day.

2 secondary outcomes

Changes in Gastrointestinal (GI) Symptoms as Measured by the Gastrointestinal Symptom Rating Scale (GSRS).
Time frame: At week 3 and week 13 (last visit)
Changes in Gastrointestinal Symptoms as Measured by the Gastrointestinal Quality of Life Index (GIQLI).
Time frame: At week 3 and week 13 (last visit)

Results and safety

Results posted to the registry on 24 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enteric-Coated Mycophenolate Sodium (EC-MPS)	69	57
Mycophenolate Mofetil (MMF)	65	53

Primary outcome: Mycophenolic Acid (MPA) Maintenance Treatment

Time frame: at week 13 (last visit). Number (95% Confidence Interval). Unit: Percentage of Patients

Measure	Enteric-Coated Mycophenolate Sodium (EC-MPS) n = 68	Mycophenolate Mofetil (MMF) n = 61
Value	47.06 (34.83 to 59.55)	16.39 (8.15 to 28.09)

Population analysed: The intent-to-treat (ITT) population consisted of all randomized patients who provided baseline and at least 1 post-baseline assessment of the primary variable.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 13 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enteric-Coated Mycophenolate Sodium (EC-MPS)	9 of 68 (13.2%)	25 of 68 (36.8%)	Not reported
Mycophenolate Mofetil (MMF)	7 of 61 (11.5%)	26 of 61 (42.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Transplant

Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

Magdi Shehata, MBBCh, MD, FRCS principal investigator

Director of Transplantation, Nottingham City Hospital, Nottingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Enteric-Coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in people with Renal Transplant, run by Novartis Pharmaceuticals at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mycophenolic Acid (MPA) Maintenance Treatment (time frame: at week 13 (last visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00239005.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2017.