Chronic Renal DiseaseNOVOSTARTNCT06960824
Real-word Study of the de NOVO Extended-release tacrolimuS in Kidney Transplantation Using an ARTificial Intelligence
An observational study of Chronic Renal Disease, run by Chiesi SAS at 1 site in France.
Trial summary
The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus [Life-Cycle Pharma Tacrolimus] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Disease
- What is being tested?
- Life-Cycle Pharma Tacrolimus and Kidney transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 165 participants
- Where
- 1 siteFrance
- Study dates
- May 2025to 31 Dec 2027
- 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: 1. Cohort of patients treated with LCPT-based immunosuppression : we will recruit all kidney recipients aged 18 years and older, regardless of gender, who have received Life-Cycle Pharma Tacrolimus (Envarsus®) once daily within 24 hours of transplantation, as judged by the investigator, and who meet the eligibility criteria. 2. Reference transplant cohort : The reference transplant cohort is composed of kidney transplant patients from four French centres (Necker, Saint-Louis, Foch and Toulouse hospitals), comprising 4,000 consecutive patients transplanted between 2005 and 2014.
Who may be able to join
- Kidney recipients aged 18 years and older.
- Kidney recipients were transplanted from living or deceased donors
- Patients receiving Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics.
- Patients are willing to participate in the study and do not oppose the use of their data.
- Patients are either affiliated with or beneficiaries of a social security scheme.
Who cannot join
- Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).
- Pre-transplant desensitization.
- ABO is incompatible with a living donor.
- Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).
- Previous bariatric (or bypass) surgery.
- Gastrointestinal problems are likely to affect the absorption of the Life-Cycle Pharma Tacrolimus (Envarsus®).
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- Diagnosis of Parkinson's disease or any other neurological syndrome causing tremor.
- Patients who are part of another clinical trial or in a period of exclusion from another clinical trial with a molecule under study.
- Pregnant women or breastfeeding.
- Patients under legal protection (guardianship, curatorship) or deprived of their liberty through judicial or administrative decisions.
- Patients under State Medical Assistance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Chru Tours
Tours, 37044
Philippe GATAULT, MD, 247366392 ext. +33, philippe.gatault@univ-tours.fr
About this study
Official title: Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study
The purpose of this study is to assess the clinical efficacy of the LCPT En-varsus [Life-Cycle Pharma Tacrolimus] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).
Read the detailed description
NovoStart is a descriptive study, prospective, multicenter, real-world evidence de-signed to evaluate the clinical efficacy and safety of Once-Daily Extended-Release Tacroli-mus in kidney transplantation using the iBox prognostic system.
The NovoStart study will be conducted at 13 academic hospitals in France performing kidney transplants.
The study population will comprise three cohorts of patients:
- Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
- Cohorts Transplant reference: two control groups (Twice-Daily Tacrolimus and Once-Daily Tac-rolimus) to determine the main secondary objective.
- Conditions
- Chronic Renal Disease
- Being tested
- Life-Cycle Pharma Tacrolimus, Kidney transplantation
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life-Cycle Pharma TacrolimusDrug
Patients receiving LCPT Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics (SmPC).
Kidney transplantationProcedure or surgery
Kidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants)
| Study group | Role | What they receive |
|---|---|---|
| Cohort of patients treated | Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective. Receives: Drug: Life-Cycle Pharma Tacrolimus; Procedure: Kidney transplantation | |
| Reference cohort for transplants | Cohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective. Receives: Procedure: Kidney transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Biopsy Proven Acute Rejection
The primary endpoint is the incidence of Biopsy Proven Acute Rejection between the Life-Cycle Pharma Tacrolimus cohort and the control groups of the transplant reference cohort.
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 posted7 May 2025
- Study startMay 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe GATAULT, MD, Principal investigator, CHRU TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960824
- Sponsor's protocol ID
- 2025-A00256-43
- Acronym
- NOVOSTART
- Status last verified
- Apr 2025
- First submitted
- 29 Apr 2025
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-word Study of the de NOVO Use of Once-daily Extended-release tacrolimuS (LCPT) in Kidney Transplantation Using an ARTificial Intelligence Prognostic System: a Multicenter Prospective Ob-servational Study
- ClinicalTrials.gov ID
- NCT06960824
- Acronym / sponsor ID
- NOVOSTART / 2025-A00256-43
- Conditions
- Chronic Renal Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Chiesi SASIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 May 2025 (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 purpose of this study is to assess the clinical efficacy of the LCPT En-varsus [Life-Cycle Pharma Tacrolimus] initiated in de novo (Day 0 of transplantation) using the Biopsy Proven Acute Re-jection and iBox (full and abbreviated algo-rithms).
Detailed description
NovoStart is a descriptive study, prospective, multicenter, real-world evidence de-signed to evaluate the clinical efficacy and safety of Once-Daily Extended-Release Tacroli-mus in kidney transplantation using the iBox prognostic system.
The NovoStart study will be conducted at 13 academic hospitals in France performing kidney transplants.
The study population will comprise three cohorts of patients:
- Cohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective.
- Cohorts Transplant reference: two control groups (Twice-Daily Tacrolimus and Once-Daily Tac-rolimus) to determine the main secondary objective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort of patients treated | – | Drug: Life-Cycle Pharma Tacrolimus, Procedure: Kidney transplantationCohort of patients treated with Life-Cycle Pharma Tacrolimus-based immunosuppression: Our single-arm study addresses the primary objective. |
| Reference cohort for transplants | – | Procedure: Kidney transplantationCohorts Transplant reference: two control groups (Tacrolimus twice daily (IR-Tac) and Tacrolimus once daily (ER-Tac)) to determine the main secondary objective. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Cohort of patients treated with LCPT-based immunosuppression : we will recruit all kidney recipients aged 18 years and older, regardless of gender, who have received Life-Cycle Pharma Tacrolimus (Envarsus®) once daily within 24 hours of transplantation, as judged by the investigator, and who meet the eligibility criteria. 2. Reference transplant cohort : The reference transplant cohort is composed of kidney transplant patients from four French centres (Necker, Saint-Louis, Foch and Toulouse hospitals), comprising 4,000 consecutive patients transplanted between 2005 and 2014.
Key inclusion criteria (5 listed)
- Kidney recipients aged 18 years and older.
- Kidney recipients were transplanted from living or deceased donors
- Patients receiving Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics.
- Patients are willing to participate in the study and do not oppose the use of their data.
- Patients are either affiliated with or beneficiaries of a social security scheme.
Key exclusion criteria (11 listed)
- Contraindications to the use of Life-Cycle Pharma Tacrolimus (Envarsus®).
- Pre-transplant desensitization.
- ABO is incompatible with a living donor.
- Combined transplant (e.g. kidney-heart transplant, kidney-liver transplant).
- Previous bariatric (or bypass) surgery.
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 |
|---|---|---|
| Life-Cycle Pharma TacrolimusPatients receiving LCPT Envarsus® [Life-Cycle Pharma Tacrolimus] within 24 hours of kidney transplantation in a once-daily formulation at the discretion of the investiga-tor and in compliance with the summary of product characteristics (SmPC). | Drug | Cohort of patients treated |
| Kidney transplantationKidney transplant patients using the iBox prognostic system (risk prediction system for kidney transplants) | Procedure or surgery | Cohort of patients treated, Reference cohort for transplants |
Primary outcome
Incidence of Biopsy Proven Acute Rejection
Time frame: 12 months
The primary endpoint is the incidence of Biopsy Proven Acute Rejection between the Life-Cycle Pharma Tacrolimus cohort and the control groups of the transplant reference cohort.
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 7 May 2025.
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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.
Philippe GATAULT, MD principal investigator
CHRU TOURS
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 Chronic Renal Disease, run by Chiesi SAS 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 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: opening soon, as of the sponsor's last update on 7 May 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?
Contact Philippe GATAULT, MD (247366392 ext. +33, philippe.gatault@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Biopsy Proven Acute Rejection (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 7 May 2025.