Intravenous Immunoglobulins for Prevention of BKV Viremia in Kidney Transplant Recipients According to BKV genotype-specific Neutralizing Antibody Titers at the day of transplantation: A Multicenter Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Les Hopitaux Universitaires De Strasbourg

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

21 Aug 2022 → ongoing

Decision date (initial)

2024-07-12

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515243-37-00

EudraCT number

2018-000695-15

ClinicalTrials.gov

NCT04222023

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of the study is to investigate the impact of a
preventive administration of IVIG on the incidence of BKV viremia (> 3
log10 copies/mL ) in patients with low titers of neutralizing antibodies
(NAbs) against the donor's BKV strain at the time of transplantation.

Secondary objectives 1

1. The secondary objectives of the study are to assess in a prospective cohort, the kinetics of BKV NAbs, the incidence of BKV diseases, graft rejection episodes, graft survival, the incidence of TTV viremia, the evolution of B and T-cell repertoire against BKV, the tolerance of IVIG; and assess BKV NAb concentration in administered IVIG

Conditions and MedDRA coding

Kidney Transplantation BKV infection

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult patients (≥ 18 years)
2. Kidney transplant recipients, including multiple organ transplant patients
3. Patients able to understand the purpose and the risks of the study, fully informed and having written informed consent
4. Affiliated to a medical insurance scheme

Exclusion criteria 10

1. BKV nephropathy during a previous transplantation in the past 5 years
2. HLA and ABO-incompatible kidney transplant recipients undergoing desensitization with rituximab and/or plasmapheresis before transplantation or susceptible to receive such therapy after transplantation
3. Patients with high risk of post- transplant Focal Segmental glomerulosclerosis recurrence
4. Patient with hyperprolinemia
5. Contraindications to the use to IVIg: hypersensitivity to the active substance or to any excipients or human immunoglobulins, especially in patients with antibodies against IgA
6. Pregnant or breast feeding women
7. Adults under guardianship or limited guardianship
8. Currently participating in another clinical trial investigating drugs (observational studies are not considered as an exclusion criterion)
9. Patients with high risk of thrombosis
10. Patients with isolated IgA deficiency French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the incidence of BKV viremia (> 3 log10 copies/mL ) 6 months after transplantation.

Secondary endpoints 15

1. BKV NAb titers at the day (D) of transplantation (D0), and D10 ,D31, D52, M3, M6 and M12
2. Incidence of BKV viruria at D10, D31, D52, M3, M6 and M12
3. Incidence of BKV viremia > 3 log10 copies/mL in at least two
4. Incidence of TTV viremia at D0, D10, D31, D52, M3, M6 and M12
5. Evolution of T and B-cell repertoire against BKV at D0, M3, M6 and M12
6. Incidence of BKV nephropathy at M3, M6, and M12
7. Time of occurrence and duration of viruria, viremia and BKVAN
8. Genotype of replicative BKV
9. The predictive value of BKV Nab titers pre-transplantation for BKV replication after transplantation
10. GFR evaluated by CKD EPI formula at M3, M6 and M12
11. Percentage of patients with donor specific antibodies (DSA) at M3 and M12
12. Incidence of biopsy proved antibody mediated rejection at M3 and M12 according to Banff classification
13. Incidence of biopsy proved acute cellular rejection at M3 and M12 according to Banff classification
14. Patient and graft survival at M12
15. Tolerance of IVIG, adverse and severe adverse effects

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Les Hopitaux Universitaires De Strasbourg

Sponsor organisation

Les Hopitaux Universitaires De Strasbourg

Address

1 Place De L Hopital, Cs 80426 Cs 80426

City

Strasbourg Cedex

Postcode

67091

Country

France

Scientific contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

Sophie CAILLARD

Public contact point

Organisation

Les Hopitaux Universitaires De Strasbourg

Contact name

Sophie CAILLARD

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 6 files

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

Application history

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