Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant RecipientsPhase 4NCT00150085
Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion
A Phase 4 study testing cyclosporine micro-emulsion in people with Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients, run by Novartis.
Trial summary
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
- What is being tested?
- cyclosporine micro-emulsion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2004to Oct 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 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
- Receiving tacrolimus as a primary immunosuppressant
- Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus
Who cannot join
- History of treated diabetes mellitus prior to transplantation
- Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
- Greater than 36 months post-transplantation
- Onset of diabetes is greater than 12 months prior to time of study entry
- Has unacceptable or unstable graft function
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Official title: A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
- Conditions
- Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
- Being tested
- cyclosporine micro-emulsion
- Keywords
- diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal
- 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 micro-emulsionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
Secondary outcomes (1)
Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks
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 startFeb 2004
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant RecipientsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00150085
- Sponsor's protocol ID
- COLO400AUS06
- Status last verified
- Feb 2011
- First submitted
- 6 Sep 2005
- Last updated
- 18 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Twenty-six Week Study of the Efficacy and Safety of Converting Kidney and Liver Transplant Recipients With Tacrolimus-associated Abnormal Glucose Metabolism to Cyclosporine Micro-emulsion With C2 Monitoring
- ClinicalTrials.gov ID
- NCT00150085
- Acronym / sponsor ID
- COLO400AUS06
- Conditions
- Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
- Keywords
- diabetes, glucose, tacrolimus, cyclosporine micro-emulsion, liver, kidney, renal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 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.
New onset diabetes mellitus (NODM) post- transplantation decreases patient and graft survival. Some immunosuppressive agents are associated with a higher incidence of NODM. This study evaluates the safety and efficacy of converting patients with NODM from tacrolimus to cyclosporine micro-emulsion as a primary immunosuppressant for kidney and liver recipients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Recipients of first or second cadaveric or living donor kidney transplantation or first cadaveric or living donor liver transplantation
- Receiving tacrolimus as a primary immunosuppressant
- Currently on any diabetic agent or meets the American Diabetes Association definition of diabetes mellitus
Key exclusion criteria (6 listed)
- History of treated diabetes mellitus prior to transplantation
- Less than 2 weeks post-transplantation for kidney and less than 8 weeks for liver
- Greater than 36 months post-transplantation
- Onset of diabetes is greater than 12 months prior to time of study entry
- Has unacceptable or unstable graft function
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 micro-emulsion | Drug | – |
Primary outcome
Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 weeks
1 secondary outcome
Safety assessed by death, graft loss, biopsy supported clinically manifested acute rejection, change in kidney function, change in liver function, serious adverse events and adverse events at 12 and 26 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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 micro-emulsion in people with Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients, 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 6 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: stopped early, as of the sponsor's last update on 18 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 was stopped early. Results are not available in the source record.
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?
Proportion of patients who no longer require a hypoglycemic agent, or who move from insulin to an oral agent, or who no longer meet the American Diabetes Association criteria, or a relative improvement in mean glycosylated hemoglobin at 12 and 26 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 18 Feb 2011.