Kidney Failure, ChronicPhase 4GLITTERNCT03640026
Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
A Phase 4 study testing Tacrolimus in people with Kidney Failure, Chronic, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Tacrolimus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Mar 2019to 10 Nov 2025
- 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
- Age ≥ 18 years
- Patient eligible for kidney transplantation at the Nantes University Hospital
- Hemodialysis patient in one of the participating centres
- Patient who is able to understand the proposed protocol and has given free and informed consent
- Patient with affiliation to the French social security system.
Who cannot join
- Personal history of diabetes treated or untreated
- Temporary contraindication for carcinological reasons
- Immunosuppressive treatment in the 6 months prior to inclusion
- Macrolide Allergies
- Hypersensitivity to the excipients used in the composition of tacrolimus
- Intolerance to the HGPO test
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- Progressive infectious outbreak
- Hepatic insufficiency
- Intercurrent infectious pathology
- Patient under guardianship, curatorship, legal protection measure, or deprived of liberty
- Pregnant women, breastfeeding, or non-menopausal woman who refuses contraception
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
Centre Hospitalier Universitaire Nantes
Nantes
About this study
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation.
In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality.
Read more
Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation.
Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function.
In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment.
No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows:
HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0
These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Tacrolimus
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacrolimusDrug
Tacrolimus will be initiated at 0.1 mg/kg/day in two separate 12-hour oral doses (capsules) for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus treatment | Experimental | Not described Receives: Drug: Tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of haemodialysis patients modifying their glycemic profile receiving Tacrolimus
Measured: During 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start8 Mar 2019
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Awena LE FUR, Principal investigator, CHD Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640026
- Sponsor's protocol ID
- CHD045-17
- Acronym
- GLITTER
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Disorders Induced by Tacrolimus on Pre Transplantation Endstage Renal Disease Patients
- ClinicalTrials.gov ID
- NCT03640026
- Acronym / sponsor ID
- GLITTER / CHD045-17
- Conditions
- Kidney Failure, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 21 Aug 2018 (actual)
- 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.
Diabetes after kidney transplantation is a frequent complication, the incidence of which varies from 7 to 45% depending on the studies and on the diagnostic criteria used. Post-transplant diabetes is an early complication, most often occurring in the first month after transplantation.
In addition to the additional health costs generated by the appearance of post-transplant diabetes, the risk of graft loss is increased by 60% and the overall mortality risk by 90%. Similarly, the development of glucose intolerance after transplantation is associated with higher mortality.
Tacrolimus treatment is therefore currently one of the most important risk factors for diabetes at the time of transplantation.
Indeed, several in vitro and in vivo animal studies have shown that tacrolimus alters pancreatic endocrine function.
In the final stage, this cellular toxicity leads to diabetes, most often diagnosed on the rise in capillary or venous blood sugar levels after transplantation. This diabetes often requires hypoglycemic treatment with insulin or oral anti-diabetic drugs. for a variable period. The pro-diabetogenic effect of tacrolimus is sometimes irreversible, justifying preventive treatment.
No clinical studies have looked at "sub-clinical" changes in insulin secretion or insulin resistance under tacrolimus prior to the onset of diabetes. The static indices HOMA-β% and HOMA-IR (Homeostasis Model Accessment of insulin resistance) make it possible to estimate insulin secretion and insulin resistance in fasting patients respectively, while the oral glucose disposition index (IDO) makes it possible to study insulin secretion and action dynamically (after a 75 g glucose load), and are calculated as follows:
HOMA IR= Fasting blood glucose (mmol/L) x Fasting insulin (mU/L)/ 22.5 HOMAβ% = 20 x fasting insulinemia (mU/L) / fasting plasma glucose (mmol/L) - 3.5 IDO = (delta insulinemia T30-T0/ delta blood glucose T30-T0)/insulinemia T0
These indices have already been studied in dialysis patients (diabetic and non-diabetic) and may allow a more detailed study of pancreatic response and insulin resistance under tacrolimus in patients prior to renal transplantation. Determining the "pancreatic response" to tacrolimus in patients prior to transplantation would prevent diabetes by adapting immunosuppressive treatment and post-transplant screening modalities in the event of pre-transplant subclinical abnormalities identified in our study. The development of tacrolimus-induced diabetes in pre-transplantation in our study will be a contraindication to tacrolimus at the time of transplantation and ciclosporin therapy will be preferred.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus treatment | Experimental | Drug: Tacrolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient eligible for kidney transplantation at the Nantes University Hospital
- Hemodialysis patient in one of the participating centres
- Patient who is able to understand the proposed protocol and has given free and informed consent
- Patient with affiliation to the French social security system.
Key exclusion criteria (11 listed)
- Personal history of diabetes treated or untreated
- Temporary contraindication for carcinological reasons
- Immunosuppressive treatment in the 6 months prior to inclusion
- Macrolide Allergies
- Hypersensitivity to the excipients used in the composition of tacrolimus
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 |
|---|---|---|
| TacrolimusTacrolimus will be initiated at 0.1 mg/kg/day in two separate 12-hour oral doses (capsules) for 14 days. | Drug | Tacrolimus treatment |
Primary outcome
Proportion of haemodialysis patients modifying their glycemic profile receiving Tacrolimus
Time frame: During 14 days
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
Awena LE FUR principal investigator
CHD Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tacrolimus in people with Kidney Failure, Chronic, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
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 5 inclusion and 11 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: Recruitment difficulties). 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 haemodialysis patients modifying their glycemic profile receiving Tacrolimus (time frame: During 14 days). 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 13 Apr 2026.