Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
310
Countries
1
Sites
13
adverse kidney events during septic shock
to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- completed 11 Sep 2025
- Decision date (initial)
- 2024-09-13
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517055-13-00
- EudraCT number
- 2020-001276-15
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy
to show the superiority of Nicotinamide supplementation compared to the placebo group, in patients with septic shock admitted to intensive care
Secondary objectives 5
- Increase in the number of days living without extra-renal treatment on day 30.
- Reduction in the incidence of major renal adverse events at day 90 (MAKE 90)
- Reducing the length of hospital stay in intensive care
- The good tolerance of Nicotinamide to the doses used in the study.
- Evaluation of the efficacy of Nicotinamide supplementation as a function of the urinary quinolonate/ tryptophan ratio on day 0 and day 1
Conditions and MedDRA coding
adverse kidney events during septic shock
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Vitamine PP Versus Placebo contrôlé, randomisé, en double aveugle comparant le nicotinamide par rapport au placebo sur l’efficacité thérapeutique
|
Randomised Controlled | Double | [{"id":128932,"code":5,"name":"Carer"},{"id":128933,"code":1,"name":"Subject"},{"id":128935,"code":4,"name":"Analyst"},{"id":128934,"code":3,"name":"Monitor"},{"id":128931,"code":2,"name":"Investigator"}] | Standard Arm: Placebo Experimental Arm: Vitamine PP |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adult patients with septic shock defined as sepsis with persisting hypotension requiring vasopressors to maintain MAP ≥65 mm Hg and having a serum lactate level >2 mmol/L (18 mg/dL) despite adequate volume resuscitation
Exclusion criteria 8
- Presence of inclusion criteria for more than 24 hours
- Immediate indication to start renal replacement therapy at the time of randomization
- Hyperkalemia≥ 6.5 mmol /l, metabolic acidosis with pH <7.15 not controlled by medical treatment, diuretic resistant acute pulmonary edema or accumulation of a toxic requiring dialysis.
- Formal indication of Nicotinamide supplementation according to the attending physician (eg pellagra, undernutrition, severe alcoholism)
- Known severe chronic kidney disease (clearance <30 ml /min) in the last 3 months preceding the setic shock or kidney transplant recipient
- Moribund patient (estimated survival less than 24 hours)
- Resuscitated cardiac arrest
- Patient admitted to intensive care for more than 5 days
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the proportion of patients meeting one or more criteria for MAKE30: inhospital mortality, receipt of new RRT, or persistent renal dysfunction defined as a final inpatient serum creatinine value ≥2 time baseline serum creatinine on day 30
Secondary endpoints 6
- The reduction in the incidence of moderate to severe AKI defined as stage 2 and 3 of the KDIGO 2012 classification.
- The increase in the number of days living without renal replacement therapy (censored at death or at day 30).
- Length of hospital stay: defined as the time between admission date of admission and discharge for subjects discharged alive from the resuscitation
- Reduction of the incidence of major renal adverse events at J90 (MAKE 90).The reduction of the intensive care unit length of stay.
- liver toxicity, checked on day 1, Day2, day 3 and day 7 (transaminases, bilirubin, alkaline phosphatase, gamma-glutamyltransferase), nausea, vomiting, headache, flushing, facial erythema
- Evaluate the effectiveness of Nicotinamide supplementation according to the urinary quinolonate/ tryptophan ratio on D0 and D1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
VITAMINE PP AGUETTANT 500 mg/5 ml, solution injectable
PRD3825990 · Product
- Active substance
- Nicotinamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11HA01 — NICOTINAMIDE
- Marketing authorisation
- 34009 300 421 0 6
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
CHLORURE DE SODIUM 0,9 % AGUETTANT, solution pour perfusion
PRD10486729 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS PERFUSION USE
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 1500 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 352 291 1 3
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
CHLORURE DE SODIUM FRESENIUS 0,9 %, solution injectable
PRD2503467 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 500 ml millilitre(s)
- Max total dose
- 1500 ml millilitre(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 34009 383 123 3 1
- MA holder
- FRESENIUS KABI FRANCE S.A.S.
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- TITECA BEAUPORT Dimitri
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- MATTOUG Salah
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 310 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Dr Jean Eric Techer
Réanimation Polyvalente et Unité de Soins Continus, 1601 Boulevard Des Justes, Bp 339, Calais
Centre Hospitalier De Dieppe
Réanimation-USC, 19 Avenue Pasteur, Cs 20219, Dieppe Cedex
Centre Hospitalier Universitaire Amiens Picardie
Anesthesia and Intensive Care Unit, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire Rouen
Réanimation Médicale, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Centre Hospitalier De Valenciennes
Réanimation, 114 Avenue Desandrouin, 59300, Valenciennes
Centre Hospitalier Public Du Cotentin
Réanimation, 46 Rue Val De Saire, 50100, Cherbourg-En-Cotentin
Centre Hospitalier De Tourcoing
Réanimation, 155 Rue Du President Coty, Bp 40619, Tourcoing Cedex
Centre Hospitalier Bethune Beuvry
Réanimation, 27 Rue Delbecque, 62660, Beuvry
Centre Hospitalier Universitaire De Caen Normandie
Réanimation Médicale, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire Amiens Picardie
Département d’Anesthésie-Réanimation, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Groupement Des Hopitaux De L'Institut Catholique De Lille
Réanimation, 115 Rue Du Grand But, Bp 50249 Lille, Lomme Cedex
Centre Hospitalier D'Abbeville
Réanimation Polyvalente, 43 Rue De L Isle, 80100, Abbeville
Chorale Du Centre Hospitalier De Lens
Réanimation Polyvalente, 99 Route De La Bassee, 62300, Lens
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_ 2024-517055-13-00 | 3.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Attestation investigateur representant injoignable 2024-517055-13-00 | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults-patient 2024-513301-30-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults-Representant 2024-513301-30-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Poursuite Patient 2024-517055-13-00 | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_Poursuite representant 2024-517055-13-00 | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G1_SmPC Vitamine PP | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-517055-13-00 | 3.3 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-23 | France | Acceptable 2024-09-12
|
2024-09-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-29 | France | Acceptable 2025-05-27
|
2025-05-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-02 | France | Acceptable 2025-05-27
|
2025-06-02 |