Kidney TransplantPhase 4NCT00171496
Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients
A Phase 4 study testing Cyclosporine microemulsion and Tacrolimus in people with Kidney Transplant, run by Novartis.
Trial summary
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Cyclosporine microemulsion and Tacrolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 693 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Mar 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First or second transplant, cadaveric or living donor
Who cannot join
- Multi-organ or dual kidney transplants
- Panel reactive antibodies >50%
- Other protocol-defined inclusion/exclusion criteria applied
About this study
Official title: A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
The purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
- Conditions
- Kidney Transplant
- Being tested
- Cyclosporine microemulsion, Tacrolimus
- Keywords
- Kidney transplant, adults, NODM, immunosuppressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine microemulsionDrug
TacrolimusDrug
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine microemulsion | Experimental | Not described Receives: Drug: Cyclosporine microemulsion |
| Tacrolimus | Active comparator | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
Secondary outcomes (7)
incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)
Measured: 6 months
Blood pressure at Months 3& 6 post-transplantation
incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
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 startOct 2003
- Primary completionMar 2006
- Study completionMar 2006
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 Kidney TransplantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 693 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
- NCT00171496
- Sponsor's protocol ID
- COLO400A2419
- Status last verified
- Nov 2016
- First submitted
- 12 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Ekmekcioglu O, Turkan S, Yildiz S, Gunes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004.
PubMed 26328072
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month Open Label, Multicenter, Randomized Study to Evaluate the Incidence of New Onset Diabetes Mellitus and Glucose Metabolism in Patients Receiving Cyclosporine Microemulsion With C-2 Monitoring Versus Tacrolimus After de Novo Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00171496
- Acronym / sponsor ID
- COLO400A2419
- Conditions
- Kidney Transplant
- Keywords
- Kidney transplant, adults, NODM, immunosuppressants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (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 purpose of this study is to evaluate the impact of tacrolimus and cyclosporine microemulsion on glucose metabolism in kidney transplant recipients and the efficacy and safety in preventing organ rejection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine microemulsion | Experimental | Drug: Cyclosporine microemulsion |
| Tacrolimus | Active comparator | Drug: Tacrolimus |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- First or second transplant, cadaveric or living donor
Key exclusion criteria (3 listed)
- Multi-organ or dual kidney transplants
- Panel reactive antibodies >50%
- Other protocol-defined inclusion/exclusion criteria applied
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 microemulsion | Drug | Cyclosporine microemulsion |
| Tacrolimus | Drug | Tacrolimus |
Primary outcome
Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.
Incidence of biopsy-proven acute rejection (BPAR) or graft loss or death within the first 6 months post-transplantation.
7 secondary outcomes
incidence of NODM or IFG within the first 3 mths post-transplantation in pts treated with cyclosporine microemulsion or tacrolimus
percentage of pts with preexisting diabetes at transplantation who have a glycosylated hemoglobin level >7% at Mths 3 &6 post-transplantation
Change over time of mean HbA1c at mths 3 &6 post-transplantation in pts w/ preexisting diabetes at transplantation
percentage of pts who switched from oral hypoglycemic agents to insulin within 3 &6 mths post-transplantation
incidence of impaired glucose tolerance (IGT) as assessed by an oral glucose tolerance test (OGTT)
Time frame: 6 months
Blood pressure at Months 3& 6 post-transplantation
incidence of BPAR or graft loss or death within the first 3 months post-transplantation, as well as the incidence of each individual event within 3 and 6 months post-transplantation.
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 18 Nov 2016.
- Results publication: PubMed 26328072Ekmekcioglu O, Turkan S, Yildiz S, Gunes ZE. Comparison of tacrolimus with a cyclosporine microemulsion for immunosuppressive therapy in kidney transplantation. Turk J Urol. 2013 Mar;39(1):16-21. doi: 10.5152/tud.2013.004.
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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 Cyclosporine microemulsion and Tacrolimus in people with Kidney Transplant, 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 1 inclusion and 3 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 18 Nov 2016. 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?
Incidence of NODM or impaired fasting glucose (IFG) in de novo kidney transplant patients receiving cyclosporine microemulsion versus in patients receiving tacrolimus within the first 6 months post-transplantation.. The study lists 2 primary outcomes in all. 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 NCT00171496, 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 18 Nov 2016.