Renal Transplant RecipientsPhase 4NCT00319189
Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients
A Phase 4 study testing Nateglinide in people with Renal Transplant Recipients and Posttransplant Diabetes Mellitus, run by University of Oslo School of Pharmacy at 1 site in Norway.
Trial summary
The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance
- What is being tested?
- Nateglinide
- How many people
- 15 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2002to Nov 2003
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Reduced glucose tolerance (fasting glucose < 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose > 6.1 mmol/L OR 2 hour glucose between >= 10.0 mmol/L)
- Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine < 200 micromol/L
Who cannot join
- Patients with indulin dependent diabetes mellitus before or after transplantation
- Planned change in daily prednisolone dose during the study period
- Haemoglobin < 8g/dL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance
The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.
- Conditions
- Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance
- Being tested
- Nateglinide
- Keywords
- Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NateglinideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose tolerance
Insuline release
Secondary outcomes (7)
Glucose oxidation
Postprandial hyperlipidemia
Glomerular filtration rate
HbA1C
Fasting glucose
Plasma nitric oxide
Plasma endothelin-1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startNov 2002
- Study completionNov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- University of Oslo School of Pharmacy
- Sponsor type
- University, hospital or other
- Investigators
- Trond Jenssen, MD, PhD, Principal investigator, Rikshospitalet, Section of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319189
- Sponsor's protocol ID
- Starlix in RTR
- Status last verified
- Apr 2006
- First submitted
- 27 Apr 2006
- Last updated
- 10 May 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT00319189
- Acronym / sponsor ID
- Starlix in RTR
- Conditions
- Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance
- Keywords
- Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- University of Oslo School of PharmacyUniversity, hospital or other
- Study start
- Nov 2002
- Study completion
- Nov 2003
- First posted
- 27 Apr 2006 (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 objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Reduced glucose tolerance (fasting glucose < 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose > 6.1 mmol/L OR 2 hour glucose between >= 10.0 mmol/L)
- Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine < 200 micromol/L
Key exclusion criteria (3 listed)
- Patients with indulin dependent diabetes mellitus before or after transplantation
- Planned change in daily prednisolone dose during the study period
- Haemoglobin < 8g/dL
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 |
|---|---|---|
| Nateglinide | Drug | – |
Primary outcome
Glucose tolerance
Insuline release
7 secondary outcomes
Glucose oxidation
Postprandial hyperlipidemia
Glomerular filtration rate
HbA1C
Fasting glucose
Plasma nitric oxide
Plasma endothelin-1
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 10 May 2006.
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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.
Trond Jenssen, MD, PhD principal investigator
Rikshospitalet, Section of Nephrology
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 Nateglinide in people with Renal Transplant Recipients and Posttransplant Diabetes Mellitus, 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 2 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 10 May 2006. 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?
Glucose tolerance. 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?
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 10 May 2006.