Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
109
Countries
6
Sites
17
Adolescent Renal Allografts
Evaluation of patient and functional graft survival of adolescent renal allograft recipients converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as compared to those of recipients remaining on CNI at 24 months post-randomization.
Key facts
- Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 25 May 2021 → ongoing
- Decision date (initial)
- 2023-03-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-501677-39-00
- EudraCT number
- 2018-000237-12
- WHO UTN
- U1111-1208-0491
- ClinicalTrials.gov
- NCT04877288
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy, Pharmacokinetic, Pharmacodynamic, Pharmacoeconomic
Evaluation of patient and functional graft survival of adolescent renal allograft recipients
converted from CNI to belatacept-based immunosuppression at least 6 months post-transplant as
compared to those of recipients remaining on CNI at 24 months post-randomization.
Conditions and MedDRA coding
Adolescent Renal Allografts
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10038533 | Renal transplant | 100000004865 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-000157-PIP01-07
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Male and females between 12 to less than 18 years of age
- Documented EBV seropositivity prior to transplant and randomization
- Receiving a stable regimen of a CNI with a mycophenolate with or without concomitant corticosteroids for > 1 calendar month prior to randomization
- Stable renal function 12 weeks prior to screening based upon investigator assessment and protocol-defined criteria for eGFR and proteinuria
Exclusion criteria 2
- No treatment for biopsy-proven acute rejection (BPAR) of any degree of severity within 6 calendar months prior to enrollment
- No history of biopsy confirmed antibody mediated rejection or Banff Grade IIA or higher acute cellular rejection with the current transplant
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of participants who survive with a functional graft with an eGFR > 30 mL/min/1.73 m2 (updated Schwartz formula), 24 months post-randomization.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD133405 · Product
- Active substance
- Belatacept
- Other product name
- BMS224818
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 5 mg/kg milligram(s)/kilogram
- Max total dose
- 3600 mg/kg milligram(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 3
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- GRANULES FOR ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 11 Other
- Max total dose
- 11 Other
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10797MIG · Substance
- Active substance
- Tacrolimus
- Pharmaceutical form
- GRANULES FOR ORAL SUSPENSION
- Route of administration
- ORAL
- Max daily dose
- 11 Other
- Max total dose
- 11 Other
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06250MIG · Substance
- Active substance
- Ciclosporin
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL
- Max daily dose
- 250 Other
- Max total dose
- 250 Other
- Max treatment duration
- 24 Month(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
Bristol-Myers Squibb Services Unlimited Company
- Sponsor organisation
- Bristol-Myers Squibb Services Unlimited Company
- Address
- Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2
- City
- Dublin 15
- Postcode
- D15 T867
- Country
- Ireland
Scientific contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Public contact point
- Organisation
- Bristol-Myers Squibb Services Unlimited Company
- Contact name
- GSM-CT
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Johns Hopkins University School of Medicine, Division of Kidney-Urologic Pathology ORL-000000136
|
Baltimore, United States | Other |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Accenture Services Pvt. Ltd. ORL-000000126
|
Bengaluru, India | Other, Data management |
| Accenture Solutions Private Limited ORG-100032592
|
Chennai, India | Data management |
| YPrime ORL-000000133
|
Malvern, United States | Other, Interactive response technologies (IRT) |
| Accenture Solutions Private Limited ORG-100032592
|
Manikonda, India | Data management |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Icon Laboratories Inc. ORG-100037135
|
Farmingdale, United States | Other, Other, Laboratory analysis |
| Wuxi Apptec Co. Ltd. ORG-100012470
|
Shanghai, China | Other |
| Q2 Solutions ORL-000000131
|
Livingston, United Kingdom | Other, Other, Laboratory analysis |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
Locations
6 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 3 | 1 |
| France | Ongoing, recruiting | 15 | 6 |
| Germany | Ongoing, recruiting | 10 | 4 |
| Italy | Authorised, recruiting | 7 | 2 |
| Netherlands | Ongoing, recruiting | 3 | 1 |
| Spain | Ended | 12 | 3 |
| Rest of world
United Kingdom
|
— | 59 | — |
Investigational sites
Pellegrin Hospital
Service Nephrologie pediatrique, Place Amelie Raba Leon, 33000, Bordeaux
Hopital Necker Enfants Malades
Service de néphrologie pédiatrique, 149 Rue De Sevres, 75015, Paris
Hospices Civils De Lyon
Service de Nephrologie Rhumatologie Dermatologie Pediatrique, 59 Boulevard Pinel, 69500, Bron
Centre Hospitalier Universitaire De Nantes
Service des maladies chroniques de l'enfant, 7 Quai Moncousu, 44000, Nantes
Robert Debre University Hospital
Service de nephrologie pediatrique, 48 Boulevard Serurier, 75019, Paris
Assistance Publique Hopitaux De Marseille
Unité de nephrologie pediatrique, 264 Rue Saint Pierre, 13005, Marseille
University Medical Center Hamburg-Eppendorf
Paediatrische Nephrologie, Klinik u. Poliklinik für Kinder- und Jugendmedizin, Haeuser O 26 O 38 Und O 50, Martinistrasse 52, Hamburg
Heidelberg University Hospital AöR
Zentrum für Kinder- und Jugendmedizin, Paediatrische Abteilung I, Im Neuenheimer Feld 430, Neuenheim, Heidelberg
Universitaetsklinikum Essen AöR
department of pediatrics II, Hufelandstrasse 55, Holsterhausen, Essen
University Hospital Cologne AöR
Klinik und Poliklinik für Kinder- und Jugendmedizin, Kerpener Strasse 62, Lindenthal, Cologne
IRCCS Istituto Giannina Gaslini
Nephrology and Kidney Transplant-UOSD Dialysis Center, Via Gerolamo Gaslini 5, 16147, Genoa
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Nefrologia Dialisi e Trapianto Renale, Piazza Polonia 94, 10126, Turin
Amsterdam UMC
Paediatric Nephrology, Meibergdreef 9, 1105 AZ, Amsterdam
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 |
|---|---|---|---|---|---|
| Belgium | 2022-08-09 | 2023-10-20 | |||
| France | 2021-07-08 | 2021-07-21 | |||
| Germany | 2022-08-18 | 2023-10-12 | |||
| Italy | 2024-03-28 | ||||
| Netherlands | 2022-09-23 | 2023-12-04 | |||
| Spain | 2021-05-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 87 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D1_Protocol_ 2022-501677-39-00_Extract Blank | N/A |
| Protocol (for publication) | D1_Protocol admin. letter _ 2022-501677-39-00_Redacted | NA |
| Protocol (for publication) | D1_Protocol_ 2022-501677-39-00_Redacted | 7 |
| Protocol (for publication) | D4_Patient facing document_MAW_for publication_IT | 1 |
| Protocol (for publication) | D4_Questionnaire_AMBS_PMBS_MAW_PedsQL_DE_statement | NA |
| Protocol (for publication) | D4_Questionnaires not for publication statement | 1 |
| Protocol (for publication) | D4_Statement on validated questionnaires under licence_IT | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_BE | 1 |
| Recruitment arrangements (for publication) | K1 Recruitment arrangements_IT | 1 |
| Recruitment arrangements (for publication) | K1_FR_Document Additionel_IM103-402_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_FR_Modalites de recrutement_IM103-402_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements_DE_CL | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted_NL | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Data Privacy Majority_IT | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Data Privacy Parents_IT | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pregnant Partner_IT | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Travel reimbursement_redacted IT | 1 |
| Subject information and informed consent form (for publication) | L1_BE_Age of Majority ICF_en_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Age of Majority ICF_nl_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Age of Majority_fr_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Assent ICF_en_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Assent ICF_fr_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Assent ICF_nl_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Main Parent ICF_en_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Main Parent ICF_fr_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_Main Parent ICF_nl_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Age of Majority ICF_en_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Age of Majority ICF_fr_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Age of Majority ICF_nl_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Assent ICF_en_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Assent ICF_fr_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Assent ICF_nl_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Main Parent ICF_en_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Main Parent ICF_fr_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_OLE_Main Parent ICF_nl_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE_Pregnant Partner IC_en_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_Pregnant Partner IC_fr_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_BE_Pregnant Partner IC_nl_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF Main 12 to 16_CL_unredacted | 7 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF Main 17 year-olds_CL_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF Main 18 year-olds_CL_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF Main Parents_CL_redacted | 8 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF OLE 12 to 16_CL | 3 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF OLE 17 year-olds_CL_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF OLE 18 year-olds_CL_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF OLE Parents_CL_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF PP 12 to 16_CL_redacted | 02 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF PP 17 year-olds_CL_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_DE_Ger_SIS and ICF PP 18 year-olds_CL_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_FR_ ICF Partenaire enceinte_FR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF 12-16 yr OLE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF 12-16 yr_Redacted | 7 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF adult OLE_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF adult_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF parents OLE_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS and ICF_parents_Redacted | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_Adolescent devenu Majeur_OLE_deja inclus_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_Adolescent devenu Majeur_OLE_nouveau patient_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_ASSENT_Adolescent_OLE_deja inclus_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_ASSENT_Adolescent_OLE_nouveau patient_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_Parents_Representant legal_OLE_deja inclus_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_Parents_Representant legal_OLE_nouveau patient_FR_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Age of Majority OLE_redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Age of Majority_redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent OLE_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ASSENT_Adolescent_Deja Inclus_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ASSENT_Adolescent_Nouveau Patient_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adolescent devenu Majeur_Deja Inclus_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adolescent devenu Majeur_nouveau patient_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parents OLE_redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parents_redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parents_Representant Legal_Deja Inclus_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Parents_Representant Legal_Nouveau Patient_FR_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research Majority_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research parent_IT | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC MODIGRAF Astellas | 21 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Neoral Novartis RSI | N/A |
| Synopsis of the protocol (for publication) | D1_EUCTR_ Protocol Synopsis__BE_2022-501677-39-00 German | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_FR_Protocol Synopsis_2022-501677-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol synopsis_BE_2022-501677-39-00_Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol synopsis_BE_2022-501677-39-00_French | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol Synopsis_ENG_2022-501677-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol synopsis_ES_2022-501677-39-00 | 2 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol Synopsis_IT_2022-501677-39-00 | 1 |
| Synopsis of the protocol (for publication) | D1_EUCTR_Protocol Synopsis_NL_2022-501677-39-00 Dutch | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2022-501677-39-00_Redacted | 1 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-22 | Netherlands | Acceptable 2023-02-08
|
2023-02-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-19 | Netherlands | Acceptable 2023-07-21
|
2023-07-24 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-11-17 | Acceptable 2023-07-21
|
2024-02-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-14 | Acceptable 2023-07-21
|
2024-03-14 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-28 | Netherlands | Acceptable 2024-08-21
|
2024-08-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-09-13 | Netherlands | Acceptable 2024-10-22
|
2024-10-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-05 | Netherlands | Acceptable 2024-10-22
|
2024-12-05 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-12-12 | Acceptable 2024-10-22
|
2024-12-12 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-27 | Acceptable | 2025-03-14 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-01-28 | Acceptable | 2025-02-07 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-07 | Netherlands | Acceptable 2025-08-19
|
2025-08-19 |
| 12 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-31 | Netherlands | Acceptable 2026-02-02
|
2026-02-02 |