Renal Transplant FailureSAVENCT04945785
" SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"
An observational study of Renal Transplant Failure, run by Nantes University Hospital at 1 site in France.
Trial summary
The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Transplant Failure
- How many people
- 226 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2021to 28 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Major patients with row 1 or 2 renal transplants (1st or 2nd transplant) rapid metabolizers defined by a C0 / D ratio <1.05 at one month post transplant, with impaired function of the graft. 75 patients will be prospectively included in the Advagraf® or Prograf® switch cohort for Envarsus® during their renal transplant follow-up. 150 patients matched on age, graft rank, type of donor (standard criteria / expanded criteria) and C0 / D at one month of grafting will constitute the retrospective control cohort extracted from the database in Nantes.
Who may be able to join
- Patient ≥ 18 years old
- 1st or 2nd kidney transplant
- Transplantation from a deceased donor (Encephalic death or arrested heart Maastricht III) or living donor
- C0 / D ratio <1.05 at one month of kidney transplant
- Renal graft function <60ml / min (eGFR estimate by CKD-EPI or MDRD).
Who cannot join
- Patient ≤ 18 years old, under guardianship or protected
- Graft rank ≥ 3
- Renal graft function <30 ml / min (eGFR estimate by CKD-EPI or MDRD)
- Presence of pre-transplant DSA (threshold> 2000 MFI)
- Occurrence of histologically proven rejection during the 1st month of transplant
- Presence of another functional transplant (heart / lung / liver / pancreas) or kidney bi-transplant
- Transplantation from a living donor
- Transplantation from an arrested heart donor Maastricht II
Trial locations and contacts
1 site in 1 country.
About this study
The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.
The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.
- Conditions
- Renal Transplant Failure
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| control | Before switch Advagraf to Envarsus Receives: Other: No intervention | |
| case | After switch Advagraf to Envarsus Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of kidney allograft between month 1 and month 12
comparison of eGFR (estimated Glomerular Filtration Rate) level at M12 by using the MDRD formula between Envarsus® and Advagraf® groups.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start28 Jul 2021
- Primary completion28 May 2025
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant FailureStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques DANTAL, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945785
- Sponsor's protocol ID
- RC20_0443
- Acronym
- SAVE
- Status last verified
- Jul 2025
- First submitted
- 1 Jun 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " SAVE Study (Switch AdVagraf® to Envarsus®) for Fast Metabolizers Kidney Transplant Recipients"
- ClinicalTrials.gov ID
- NCT04945785
- Acronym / sponsor ID
- SAVE / RC20_0443
- Conditions
- Renal Transplant Failure
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 30 Jun 2021 (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.
The use of calcineurin inhibitors (CNIs) in kidney transplantation is the gold standard treatment to prevent episodes of rejection. Nevertheless, CNIs have side effects and are in particular nephrotoxic for the kidney transplant. Monitoring CNI dosages is fundamental for the clinician, in order to find the right balance between toxicity and prevention of rejection. Several recent studies suggest that a Radio Residual Concentration / Dosage (C0 / D) less than 1.05 (patients with rapid metabolizers) is associated with poor graft function (eGFR) and decreased kidney transplant survival. LCPT prolonged-release tacrolimus (Novel Once-Daily Extended-Release Tacrolimus. Prolonged-release tacrolimus: Envarsus®) is a marketed form of tacrolimus with interesting pharmacokinetic properties: daily intake, reduction of the absorption peak (Meltodose® technology ) and reduction of the total CNI dose by 30% to obtain an equivalent CO compared to other molecules on the market (Advagraf®, Prograf®). Thus, the use of LCPT in patients rapid metabolisers in relay of Advagraf® or Prograf® could make it possible to decrease renal toxicity while preserving rejection, by increasing the C0 / D ratio.
The investigators propose a pilot study aiming to study a prospective cohort of rapid metabolisers patients put on Envarsus at one month of transplant compared to a historical cohort, in terms of C0 / D ratio, function and survival of the renal graft.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: No interventionBefore switch Advagraf to Envarsus |
| case | – | Other: No interventionAfter switch Advagraf to Envarsus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patients with row 1 or 2 renal transplants (1st or 2nd transplant) rapid metabolizers defined by a C0 / D ratio <1.05 at one month post transplant, with impaired function of the graft. 75 patients will be prospectively included in the Advagraf® or Prograf® switch cohort for Envarsus® during their renal transplant follow-up. 150 patients matched on age, graft rank, type of donor (standard criteria / expanded criteria) and C0 / D at one month of grafting will constitute the retrospective control cohort extracted from the database in Nantes.
Key inclusion criteria (5 listed)
- Patient ≥ 18 years old
- 1st or 2nd kidney transplant
- Transplantation from a deceased donor (Encephalic death or arrested heart Maastricht III) or living donor
- C0 / D ratio <1.05 at one month of kidney transplant
- Renal graft function <60ml / min (eGFR estimate by CKD-EPI or MDRD).
Key exclusion criteria (8 listed)
- Patient ≤ 18 years old, under guardianship or protected
- Graft rank ≥ 3
- Renal graft function <30 ml / min (eGFR estimate by CKD-EPI or MDRD)
- Presence of pre-transplant DSA (threshold> 2000 MFI)
- Occurrence of histologically proven rejection during the 1st month of transplant
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 |
|---|---|---|
| No interventionno intervention | Other | case, control |
Primary outcome
Improvement of kidney allograft between month 1 and month 12
Time frame: 12 months
comparison of eGFR (estimated Glomerular Filtration Rate) level at M12 by using the MDRD formula between Envarsus® and Advagraf® groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jacques DANTAL principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Transplant Failure, run by Nantes University Hospital at 1 site 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 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Jul 2025. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Improvement of kidney allograft between month 1 and month 12 (time frame: 12 months). 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 Jul 2025.