Kidney Maintenance TransplantPhase 4NCT00150007
Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
A Phase 4 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney Maintenance Transplant, run by Novartis Pharmaceuticals.
Trial summary
The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Maintenance Transplant
- What is being tested?
- Enteric-coated Mycophenolate sodium (EC-MPS)
- How many people
- 335 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Jun 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Received kidney transplant at least 1 month prior to study enrollment;
- Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment;
- Eligible to convert to EC-MPS because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen;
- At least 18 years of age;
- Willing to provide written informed consent; and
- Able to meet all study requirements including completing paper questionnaires and completing two study visits.
Who cannot join
- GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates 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 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.
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.
- Conditions
- Kidney Maintenance Transplant
- Being tested
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Keywords
- Kidney, maintenance transplant, GI complaints, patient reported outcome
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Gastro intestinal (GI) symptom severity and health-related quality of life (HRQoL) in patients with GI complaints who are converted from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS)
Secondary outcomes (1)
Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Maintenance 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150007
- Sponsor's protocol ID
- CERL080A2407
- Status last verified
- Nov 2011
- First submitted
- 26 Aug 2005
- Last updated
- 13 Sep 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Patient Reported Outcomes in Renal Transplant Patients With and Without Gastrointestinal (GI) Symptoms (PROGIS)
- ClinicalTrials.gov ID
- NCT00150007
- Acronym / sponsor ID
- CERL080A2407
- Conditions
- Kidney Maintenance Transplant
- Keywords
- Kidney, maintenance transplant, GI complaints, patient reported outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2005 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the impact that GI complaints have on patient reported outcomes in renal transplant recipients and to determine if there is improvement in patient reported outcomes when patients are converted to a EC-MPS-based immunosuppressive treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Received kidney transplant at least 1 month prior to study enrollment;
- Receiving immunosuppressive regimen that includes MMF for at least 2 weeks prior to study enrollment;
- Eligible to convert to EC-MPS because of GI complaints OR not currently experiencing GI complaints and stable on current immunosuppressive regimen;
- At least 18 years of age;
- Willing to provide written informed consent; and
Key exclusion criteria (8 listed)
- GI symptoms assumed or known not to be caused by MPA therapy (e.g. oral biphosphonates 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 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) | Drug | – |
Primary outcome
Improvement in Gastro intestinal (GI) symptom severity and health-related quality of life (HRQoL) in patients with GI complaints who are converted from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS)
1 secondary outcome
Impact of GI symptoms on patients' perceptions of symptom severity, GI-specific HRQoL, and general HRQoL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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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 study director
Novartis
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Enteric-coated Mycophenolate sodium (EC-MPS) in people with Kidney Maintenance Transplant, run by Novartis Pharmaceuticals.
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 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Gastro intestinal (GI) symptom severity and health-related quality of life (HRQoL) in patients with GI complaints who are converted from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2017.