Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial

2023-507544-37-00 Protocol 23-0164 (APIDP2) Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 8 Jan 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 20 sites · Protocol 23-0164 (APIDP2)

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 178
Countries 1
Sites 20

patients with end-stage renal disease on chronic peritoneal dialysis and with non-valvular atrial fibrillation

To compare the safety of apixaban versus warfarin, comparing the incidence of the endpoint Bleeding

Key facts

Sponsor
Centre Hospitalier Universitaire De Caen Normandie
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Phenomena and Processes [G] - Reproductive and Urinary Physiological Phenomena [G08]
Trial duration
8 Jan 2025 → ongoing
Decision date (initial)
2024-05-24
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
CHU CAEN Normandie

External identifiers

EU CT number
2023-507544-37-00
ClinicalTrials.gov
NCT06045858

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic

To compare the safety of apixaban versus warfarin, comparing the incidence of the endpoint Bleeding

Secondary objectives 3

  1. To compare the effectiveness of apixaban versus warfarin, comparing the incidence of the stroke endpoint
  2. Compare other major events: myocardial infarction, mortality
  3. Pharmacodynamics

Conditions and MedDRA coding

patients with end-stage renal disease on chronic peritoneal dialysis and with non-valvular atrial fibrillation

VersionLevelCodeTermSystem organ class
25.1 LLT 10008831 Chronic ambulatory peritoneal dialysis 10042613

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Men and women, aged at least 18 years, with end-stage renal disease (ESRD) treated with peritoneal dialysis for ≥ 3 months.
  2. Patients with a history of non-valvular atrial fibrillation treated with oral anticoagulation or patients starting oral anticoagulation for a diagnosis of non-valvular atrial fibrillation
  3. CHA2DS2-VASc score ≥ 2.
  4. For women of childbearing age and sexually active, use of an effective method of contraception
  5. Signing of informed consent
  6. Affiliation to a social security scheme

Exclusion criteria 13

  1. Patients not considered candidates for oral anticoagulation (active bleeding, recent gastrointestinal bleeding, severe hepatic impairment)
  2. Patient with history of TIA or stroke in the 3 months preceding inclusion
  3. Patient treated with hemodialysis (hybrid dialysis)
  4. Moderate or severe mitral stenosis
  5. Conditions other than non-valvular atrial fibrillation requiring anticoagulation, such as mechanical prosthetic valves, anti-phospholipid syndrome
  6. Life expectancy less than 3 months
  7. Registration on the waiting list for a kidney transplant with a cadaveric donor
  8. Pregnant or breastfeeding woman
  9. Patient under legal protection (Curatelle-Tutelle – Protection of justice)
  10. History of anaphylactic reaction to apixaban
  11. Use of millepertuis (potent CYP3A4 inducer).
  12. - Use of powerful inhibitors of CYP3A4 and gp-P: o azole antifungals (ketoconazole, itraconazole, voriconazole, posaconazole, miconazole - systemic route and oral gel) o HIV protease inhibitors.
  13. Taking acetylsalicylic acid in doses of 500 mg per dose to 3 g per day

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Clinically significant major or non-major bleeding [Period: from randomization to Month 12]. ISTH score (primary), Gusto, TIMI (secondary).

Secondary endpoints 5

  1. Stroke or systemic embolism [Period: From randomization until Month 12].
  2. Myocardial infarction [Period: From randomization until Month 12].
  3. Death from any cause [Period: From randomization until Month 12].
  4. INR values, interpretation by Rosendaal method
  5. antiXa activity of apixaban at M1, M6, M12, and in case of bleeding.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Warfarin

SUB00090MIG · Substance

Active substance
Warfarin
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Warfarin Sodium

SUB05128MIG · Substance

Active substance
Warfarin Sodium
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
10 mg milligram(s)
Max total dose
10 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Apixaban

SUB25425 · Substance

Active substance
Apixaban
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
5 mg milligram(s)
Max total dose
5 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

8 Total trials 5 Recruiting
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire De Caen Normandie
Address
Avenue De La Cote De Nacre, Cs 30001 Cs 30001
City
Caen Cedex 9
Postcode
14033
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire De Caen Normandie
Contact name
coordinator

Public contact point

Organisation
Centre Hospitalier Universitaire De Caen Normandie
Contact name
coordinator

Locations

1 EU/EEA country · 20 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Ongoing, recruiting 178 20
Rest of world — 0 —

Investigational sites

France

20 sites · Ongoing, recruiting
Expansion Centres Hemodialyse Ouest
Néphrologie, 85 Rue Saint Jacques, 44200, Nantes
Centre Hospitalier De Valenciennes
Néphrologie, 114 Avenue Desandrouin, 59300, Valenciennes
Centre Hospitalier Universitaire De Toulouse
Néphrologie, 9 Place Lange, 31300, Toulouse
Centre Hospitalier Regional De Marseille
Néphrologie, 80 Rue Brochier, 13005, Marseille
Institut Phoceen De Nephrologie
Néphrologie, 77 Rue Du Docteur Escat, 13006, Marseille
Ctre Hospitalier Moulins Yzeure
Néphrologie, 10 Avenue Du General De Gaulle, Bp 609, Moulins Cedex
Centre Hospitalier Universitaire De Caen Normandie
Néphrologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier De Boulogne Sur Mer
Néphrologie, 12 Allee Jacques Monod, 62200, Boulogne-Sur-Mer
Centre Hospitalier Departemental Vendee
Néphrologie, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Centre Hospitalier Public Du Cotentin
Néphrologie, 46 Rue Val De Saire, 50100, Cherbourg-En-Cotentin
Centre Hospitalier Bethune Beuvry
Néphrologie, 27 Rue Delbecque, 62660, Beuvry
Centre Hospitalier Universitaire De Bordeaux
Néphrologie, 12 Rue Dubernat, Cs 91286, Talence
Centre Hospitalier D Avignon
Néphrologie, 305 Rue Raoul Follereau, 84000, Avignon
Hopital Memorial France Etats Unis
Néphrologie, 715 Rue Henri Dunant, 50000, St Lo
Centre Hospitalier Universitaire De Lille
Néphrologie, 2 Avenue Oscar Lambret, Cs 70001, Lille Cedex
Hopital Prive Saint Martin-Caen
Néphrologie, 18 Rue Des Roquemonts, 14000, Caen
Les Hopitaux Universitaires De Strasbourg
Néphrologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Annecy Genevois
Néphrologie, 1 Avenue De L Hopital, Bp 90074 Epagny Metz Tessy, Pringy Cedex
Centre Hospitalier Bretagne Atlantique
Néphrologie, 20 Boulevard General Maurice Guillaudot, 56000, Vannes
Expansion Centres Hemodialyse Ouest
Néphrologie, 194 Avenue Rubillard, 72000, Le Mans

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
France 2025-01-08 2025-01-08

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) 2023-507544-37-00_PROTOCOL_APIDP2 3
Protocol (for publication) 2023-507544-37-00_protocolesigne_APIDP2 3
Recruitment arrangements (for publication) 2023-507544-37-00_INFORMATION_RECRUTEMENT_APIDP2 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT COUMADINE_M1 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT COUMADINE_M12 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT COUMADINE_M6 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT ELIQUIS_M1 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT ELIQUIS_M12 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CARNET PATIENT ELIQUIS_M6 1
Subject information and informed consent form (for publication) 2023-507544-37-00_CE_APIDP2 2
Subject information and informed consent form (for publication) 2023-507544-37-00_DI_APIDP2 2
Summary of Product Characteristics (SmPC) (for publication) SmPC_APIXABAN_2 5mg 1
Summary of Product Characteristics (SmPC) (for publication) SmPC_COUMADINE_2mg 1
Summary of Product Characteristics (SmPC) (for publication) SmPC_COUMADINE_5mg 1
Synopsis of the protocol (for publication) 2023-507544-37-00_RESUME_FR_APIDP2 3
Synopsis of the protocol (for publication) 2023-507544-37-00_RESUME_surligne_MS1_APIDP2 3

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-02-19 France Acceptable
2024-05-23
 2024-05-24
2 SUBSTANTIAL MODIFICATION SM-1 2025-07-16 France Acceptable
2025-09-05
 2025-09-12

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