Chronic Renal FailurePhase 4NCT00139035
Effects of Cyclosporine A on Pancreatic Insulin Secretion
A Phase 4 study testing cyclosporine A in people with Chronic Renal Failure, run by University of Oslo School of Pharmacy at 1 site in Norway.
Trial summary
Our primary aim is to investigate if cyclosporine A reduces insulin secretion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Renal Failure
- What is being tested?
- cyclosporine A
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2005to Jan 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Renal failure patients on dialysis which is planned to receive a renal transplant
Who cannot join
- Age below 18 years or above 75 years
- Pregnancy
- Breast feeding mothers
- Diabetes mellitus /WHO criteria)
- Dialysis treatment less than 2 months
- Serious coronary heart disease
Show all 10Show fewer
- Unstable angina pectoris
- Recent acute infarction (less than 3 months)
- Non-compensated heart failure
- Simultaneous treatment with glucocorticosteroids (e.g. prednisolone, dexamethasone), diltiazem, verapamil, erythromycin, clarithromycin, telithromycin, rifampicin, fluconazole, itraconazole, ketoconazole, voriconazole, indinavir, nelfinavir, ritonavir, nefazodone, bosentan, carbamazepine, St. John's worth, grapefruit.
Trial locations and contacts
1 site in 1 country.
About this study
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.
Read the detailed description
Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.
- Conditions
- Chronic Renal Failure
- Being tested
- cyclosporine A
- Keywords
- glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation
- Medical subject headings
- Kidney Failure, Chronic, Glucose Intolerance, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclosporine ADrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin secretion
Secondary outcomes (3)
Peripheral insulin sensitivity
Endothelial function
Pharmacokinetics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal FailureStudies 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
- 16 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Investigators
- Anders Åsberg, MSc, Study director, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00139035
- Sponsor's protocol ID
- CsA-Dialysis 2004-004488-3
- Status last verified
- Oct 2012
- First submitted
- 29 Aug 2005
- Last updated
- 2 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cyclosporine A on Pancreatic Insulin Secretion
- ClinicalTrials.gov ID
- NCT00139035
- Acronym / sponsor ID
- CsA-Dialysis 2004-004488-3
- Conditions
- Chronic Renal Failure
- Keywords
- glucose intolerance, insulin, microvascular function, genotyping, CYP3A5, pharmacokinetics, renal transplantation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jan 2006 (actual)
- First posted
- 30 Aug 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.
Our primary aim is to investigate if cyclosporine A reduces insulin secretion.
Detailed description
Our primary aim is to investigate if cyclosporine A may reduce insulin secretion by 20% or more. In order to get cyclosporine A naïve patients we will perform this investigation in dialysis patients on the waiting list for a renal transplantation. In addition we will investigate if also the peripheral insulin sensitivity and endothelia function is affected by cyclosporine A treatment in these patients. Since these patients will be treated with cyclosporine A we will also measure cyclosporine pharmacokinetics at the time of investigation and repeat this investigation at the time of the first week following transplantation in order to evaluate if a pretransplant cyclosporine dose can be of value in predefining the dose to be used at the time of transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Renal failure patients on dialysis which is planned to receive a renal transplant
Key exclusion criteria (10 listed)
- Age below 18 years or above 75 years
- Pregnancy
- Breast feeding mothers
- Diabetes mellitus /WHO criteria)
- Dialysis treatment less than 2 months
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 A | Drug | – |
Primary outcome
Insulin secretion
3 secondary outcomes
Peripheral insulin sensitivity
Endothelial function
Pharmacokinetics
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 2 Nov 2012.
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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.
Anders Åsberg, MSc study director
University of Oslo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cyclosporine A in people with Chronic Renal Failure, run by University of Oslo School of Pharmacy at 1 site in Norway.
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 10 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 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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.
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?
Insulin secretion. 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 2 Nov 2012.