A long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation and a non-comparative transplanted patient group

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Hansa Biopharma AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

3 Jul 2023 → ongoing

Decision date (initial)

2024-02-05

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Hansa Biopharma AB

External identifiers

EU CT number

2022-502727-21-00

ClinicalTrials.gov

NCT05937750

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate long-term graft failure-free survival in highly sensitised kidney transplant patients after imlifidase administration in trial 20-MedIdeS-19 (PAES) (imlifidase cohort only)

Secondary objectives 11

1. Evaluate graft failure-free survival
2. Evaluate renal function
3. Evaluate patient survival
4. Evaluate graft survival
5. Evaluate Human Leukocyte Antigen (HLA)/Donor Specific Antibodies (DSA) levels (imlifidase cohort only)
6. Evaluate long-term immunogenicity by anti-drug antibodies (ADA) (imlifidase cohort only)
7. Evaluate the proportion of patients (%) with biopsy- and serology (DSA)-confirmed Antibody Mediated Rejections (AMRs)
8. Evaluate the proportion of patients (%) with biopsy confirmed Cell-Mediated Rejections (CMRs)
9. Evaluate long-term safety of imlifidase (imlifidase cohort only)
10. Evaluate long-term clinical outcomes related to maintenance immunosuppression in terms of treatments and comorbidity
11. Evaluate patient-reported data regarding the impact of transplantation on quality of life (QoL)

Conditions and MedDRA coding

Highly sensitised patients who have undergone kidney transplantation after Idefirix (imlifidase) administration and less sensitized patients transplanted with compatible kidney transplant, serving as concurrent reference cohort

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Signed Informed Consent obtained before any trial-related procedures.
2. Willingness and ability to comply with the protocol.
3. Previously transplanted in the clinical trial 20-HmedIdeS-19 (PAES).

Exclusion criteria 1

1. Inability by the judgment of the investigator to participate in the trial for other reasons.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Graft failure-free survival (%) up to 5 years after imlifidase enabled transplantation(imlifidase cohort only)

Secondary endpoints 14

1. Graft failure-free survival (%) up to 5 years after transplantation (non-comparativeconcurrent reference cohort only)
2. Graft failure-free survival (%) up to 2 and 3 years after transplantation
3. Renal function as evaluated by estimated Glomerular Filtration Rate (eGFR) andserum/plasma creatinine levels
4. Patient survival (%) after transplantation
5. Graft survival (%) after transplantation
6. HLA/DSA levels (imlifidase cohort only)
7. ADA levels (imlifidase cohort only)
8. Proportion of patients (%) with biopsy- and serology (DSA)-confirmed AMRs
9. Proportion of patients (%) with biopsy confirmed CMRs.
10. Treatment of graft rejection episodes
11. Adverse events (AEs)/serious adverse events (SAEs) suspected to be related toimlifidase treatment (imlifidase cohort only)
12. Ongoing immunosuppressive medication
13. Comorbidity
14. Change in patient reported life participation, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health domain “Ability to participate in social roles & activities, PROMIS-SF-8a”, from baseline to 5 years after transplantation

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hansa Biopharma AB

Sponsor organisation

Hansa Biopharma AB

Address

P. O. Box 785

City

Lund

Postcode

220 07

Country

Sweden

Scientific contact point

Organisation

Hansa Biopharma AB

Contact name

Clinical contact information

Public contact point

Organisation

Hansa Biopharma AB

Contact name

Clinical contact information

Third parties 8

Locations

8 EU/EEA countries · 16 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 72 files

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

Application history

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