Maintenance Liver Transplant Patients With New Onset DiabetesPhase 4NCT00171717
Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant
A Phase 4 study testing Cyclosporine - cyclosporine microemulsion in people with Maintenance Liver Transplant Patients With New Onset Diabetes, run by Novartis.
Trial summary
The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Maintenance Liver Transplant Patients With New Onset Diabetes
- What is being tested?
- Cyclosporine - cyclosporine microemulsion
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Dec 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- - Patients who have received a first liver transplantation and who are 18 to 70 year old
- Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
- Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation
Who cannot join
- Re-transplantation or multi-organ transplantation,
- Diabetes before the transplantation,
- Type I diabetes mellitus.
- Other protocol-defined inclusion / exclusion criteria may apply
About this study
Official title: Pilot Study of the Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients Presenting With New Onset Diabetes After the 3rd Month Post-transplant.
The trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.
- Being tested
- Cyclosporine - cyclosporine microemulsion
- Keywords
- Cyclosporine, liver transplantation, maintenance, diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine - cyclosporine microemulsionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
Secondary outcomes (7)
% of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
% of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
% of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
% of patients receiving antihypertensive treatment),
BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
Incidence of acute and chronic rejection treated at 6 months and at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startFeb 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Maintenance Liver Transplant Patients With New Onset DiabetesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171717
- Sponsor's protocol ID
- COLO400AFR04
- Status last verified
- Jan 2011
- First submitted
- 13 Sep 2005
- Last updated
- 1 Feb 2011
- Results posted
- No
Publications
Lorho R, Hardwigsen J, Dumortier J, Pageaux GP, Durand F, Bizollon T, Blanc AS, Di Giambattista F, Duvoux C. Regression of new-onset diabetes mellitus after conversion from tacrolimus to cyclosporine in liver transplant patients: results of a pilot study. Clin Res Hepatol Gastroenterol. 2011 Jun;35(6-7):482-8. doi: 10.1016/j.clinre.2011.03.008. Epub 2011 May 6.
PubMed 21530445
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients Presenting With New Onset Diabetes After the 3rd Month Post-transplant.
- ClinicalTrials.gov ID
- NCT00171717
- Acronym / sponsor ID
- COLO400AFR04
- Keywords
- Cyclosporine, liver transplantation, maintenance, diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 15 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 trial is conducted in patients who have received a liver transplant, were prescribed tacrolimus to prevent organ rejection and developed diabetes from 3 month post-transplantation onwards. The goal of the trial is to assess the percentage of patients in whom diabetes will resolve 6 month after conversion from tacrolimus to cyclosporine micro-emulsion as measured by a fasting blood glucose < 1,26 g/l without the need of hypoglycemic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Patients who have received a first liver transplantation and who are 18 to 70 year old
- Patients who are treated with tacrolimus post-transplant for at least 3 months and for a maximum of 36 months
- Patients without any known diabetes before transplantation and in whom diabetes mellitus was diagnosed for the first time at least 3 months post-transplantation
Key exclusion criteria (4 listed)
- Re-transplantation or multi-organ transplantation,
- Diabetes before the transplantation,
- Type I diabetes mellitus.
- Other protocol-defined inclusion / exclusion criteria may apply
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 |
|---|---|---|
| Cyclosporine - cyclosporine microemulsion | Drug | – |
Primary outcome
% of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
7 secondary outcomes
% of patients whose diabetes has resolved 1 year after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).
% of patients treated with insulin and oral ant diabetics and status of the drug doses 6 months and 1 year after the conversion.
% of patients with HbA1c ≤ 7% 6 months and 1 year after the conversion.
Blood pressure % of patients with a diastolic value ≥ 90 mmHg, mean systolic and diastolic values,
% of patients receiving antihypertensive treatment),
BMI, kidney function (creatinine and creatinine clearance), microalbuminuria, hyperlipidemia, adverse events, serious adverse events, dropouts, at 6 months and at 1 year.
Incidence of acute and chronic rejection treated at 6 months and at 1 year.
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 1 Feb 2011.
- Derived from this study: PubMed 21530445Lorho R, Hardwigsen J, Dumortier J, Pageaux GP, Durand F, Bizollon T, Blanc AS, Di Giambattista F, Duvoux C. Regression of new-onset diabetes mellitus after conversion from tacrolimus to cyclosporine in liver transplant patients: results of a pilot study. Clin Res Hepatol Gastroenterol. 2011 Jun;35(6-7):482-8. doi: 10.1016/j.clinre.2011.03.008. Epub 2011 May 6.
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 Cyclosporine - cyclosporine microemulsion in people with Maintenance Liver Transplant Patients With New Onset Diabetes, run by Novartis.
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 3 inclusion and 4 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 1 Feb 2011. 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?
% of patients whose diabetes resolves 6 months after the conversion (fasting glucose < 1.26 g/L without hypoglycemic treatment).. 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 NCT00171717, which also lists 1 linked publication.
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 1 Feb 2011.