Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
20
Countries
1
Sites
2
Hemodialysis
Determine the proportion of hemodialysis patients who change their glycemic profile on Tacrolimus
Key facts
- Sponsor
- Centre Hospitalier Departemental Vendee
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Phenomena and Processes [G] - Metabolism [G03]
- Trial duration
- 8 Mar 2019 → 8 Apr 2026
- Decision date (initial)
- 2024-06-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514072-40-00
- EudraCT number
- 2018-001024-19
- ClinicalTrials.gov
- NCT03640026
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
Determine the proportion of hemodialysis patients who change their glycemic profile on Tacrolimus
Conditions and MedDRA coding
Hemodialysis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- ≥ 18 years old
- Patient eligible for a kidney transplant at Nantes University Hospital
- Hemodialysis patient in one of the participating centers
- Patient able to understand the proposed protocol and having given free and informed consent
- Patient with social security coverage
Exclusion criteria 11
- Personal history of treated or untreated diabetes
- Temporary contraindication for carcinological reasons
- Immunosuppressive treatment in the 6 months prior to inclusion
- Macrolide allergies
- Hypersensitivity to excipients in the composition of tacrolimus
- Intolerance to the HGPO test
- Infectious outbreak
- Liver failure
- Intercurrent infectious pathology
- Patients under guardianship, curatorship, legal protection, or deprived of liberty
- Pregnant, breast-feeding or premenopausal women refusing contraception
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Significant change in glycemic profile between D0 (before the start of treatment) and D14 (after 14 days of tacrolimus treatment)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP133064 · ATC
- Active substance
- Tacrolimus
- Substance synonyms
- TACROLIMUS ANHYDROUS
- Route of administration
- ORAL USE
- Max daily dose
- 0.1 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.1 mg/kg milligram(s)/kilogram
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AD02 — TACROLIMUS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Departemental Vendee
- Sponsor organisation
- Centre Hospitalier Departemental Vendee
- Address
- Boulevard Stephane Moreau
- City
- La Roche Sur Yon Cedex 9
- Postcode
- 85925
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Public contact point
- Organisation
- Centre Hospitalier Departemental Vendee
- Contact name
- Chloé MOREAU
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Nantes
Nephrology, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Departemental Vendee
Nephrology, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2019-03-08 | 2024-07-09 | 2026-04-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | PROTOCOL | 10.0 |
| Protocol (for publication) | Protocol_TC | 10.0 |
| Protocol (for publication) | Tableau differentiel V6-V7 | 1 |
| Protocol (for publication) | Tableau differentiel V7-V8 | 1 |
| Protocol (for publication) | Tableau differentiel V8-V9 | 1 |
| Recruitment arrangements (for publication) | document additionnel | 1 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form | 4.0 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form_TC | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_PROGRAF_0.5mg_20250417 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_PROGRAF_1mg_20250417 | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_PROGRAF_5mg_20250417 | 1.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 9.0 |
| Synopsis of the protocol (for publication) | Protocol synopsis_TC_SM01_2024-512470-10-00 | 9.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | France | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | France | Acceptable 2024-07-09
|
2024-07-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-02 | France | Acceptable 2024-10-21
|
2024-10-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-10 | France | Acceptable 2025-03-04
|
2025-03-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-26 | France | Acceptable 2025-10-20
|
2025-10-28 |