Kidney TransplantationPROGISNCT01300416
Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms
An observational study of Kidney Transplantation and GI Symptoms Severity, run by Novartis Pharmaceuticals at 9 sites in Malaysia.
Trial summary
This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, GI Symptoms Severity
- How many people
- 101 participants
- Where
- 9 sitesMalaysia
- Study dates
- Jul 2010to Jul 2012
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Kidney transplanted Patients currently on MMF who have GI symptoms and will be converted to EC-MPS treatment and patients currently on MMF without GI symptoms who will continue with MMF therapy.
Who may be able to join
- Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
- Eligible to convert to myfortic 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 be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
- Breast-feeding or pregnant woman.
- Patients with psychiatric illness.
- Underlying acute medical intervention or hospitalization
- Receiving investigational drug within 30days prior to study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Malaysia9 sites
Hospital Universiti Kebangsaan Malaysia
Cheras
Hospital Raja Perempuan Zainab II
Kota Bharu
Hospital Queen Elizabeth
Kota Kinabalu
Hospital Kuala Lumpur
Kuala Lumpur
Hospital Tengku Ampuan Afzan
Kuantan
Hospital Umum Sarawak
Kuching
Hospital Pulau Pinang
Pulau Pinang
Hospital Selayang
Selayang Baru Utara
Hospital Serdang
Serdang
About this study
Official title: Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)
This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.
- Conditions
- Kidney Transplantation, GI Symptoms Severity
- Keywords
- Kidney transplantation, mycophenolate sodium, EC-MPS, Health Related Quality of Life, GI symptoms, Immunosuppressants, HRQL, PGWB, GIQLI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With Gastro-Intestinal (GI) symptoms | Not described | |
| Without GI symptoms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.
Measured: 4-6 weeks
Secondary outcomes (1)
To identify and evaluate quality of life and impact on symptom severity based on patients perception.
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300416
- Sponsor's protocol ID
- CERL080AMY02
- Acronym
- PROGIS
- Status last verified
- Mar 2016
- First submitted
- 17 Feb 2011
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Multi-centre, Non-interventional, Observational Study to Characterize the Impact That GI Complaints Have on Patient-reported Outcomes in Patients Who Have Had a Renal Transplant. Patients Will be Evaluated at Visit 1 and Then Again After 4 (+2) Weeks (Visit 2)
- ClinicalTrials.gov ID
- NCT01300416
- Acronym / sponsor ID
- PROGIS / CERL080AMY02
- Conditions
- Kidney Transplantation, GI Symptoms Severity
- Keywords
- Kidney transplantation, mycophenolate sodium, EC-MPS, Health Related Quality of Life, GI symptoms, Immunosuppressants, HRQL, PGWB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Feb 2011 (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.
This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Gastro-Intestinal (GI) symptoms | – | – |
| Without GI symptoms | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney transplanted Patients currently on MMF who have GI symptoms and will be converted to EC-MPS treatment and patients currently on MMF without GI symptoms who will continue with MMF therapy.
Key inclusion criteria (5 listed)
- Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
- Eligible to convert to myfortic 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.
Key exclusion criteria (5 listed)
- GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
- Breast-feeding or pregnant woman.
- Patients with psychiatric illness.
- Underlying acute medical intervention or hospitalization
- Receiving investigational drug within 30days prior to study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints.
Time frame: 4-6 weeks
1 secondary outcome
To identify and evaluate quality of life and impact on symptom severity based on patients perception.
Time frame: 4-6 weeks
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 24 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and GI Symptoms Severity, run by Novartis Pharmaceuticals at 9 sites in Malaysia.
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 5 inclusion and 5 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Malaysia. 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.
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?
To determine if GI symptoms severity and health related quality of life of patients has improved after being converted from MMF to EC-MPS due to GI complaints. (time frame: 4-6 weeks). 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 24 Mar 2016.