INTERCEPT Study

Phase 1

Recruiting

• Conditions: Chronic active antibody-mediated rejection in kidney transplant recipients; Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]

• Registration Number: CTIS2024-510615-29-00
• Lead Sponsor: Vaestra Goetalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The subject has given their written informed consent to participate in the trial., Recipient of living donor or deceased donor kidney transplant, Age =18 years, At least 6 months post-transplantation at randomization, Biopsy-proven diagnosis of caAMR according to the Banff 2019 criteria in index biopsy [Repeat biopsy and DSA-testing if required for diagnosis should be performed 2 months ± 2 weeks if the patient has received any treatment for caAMR after the initial diagnostic biopsy or at randomization if the last biopsy is older than 12 months (+ 2 weeks) at randomization (Visit 2)]., eGFR =20 ml/min/1.73 m2 (not older than 1 month at randomization)., EBV IgG-positive, For female participants of childbearing potential: use of adequate contraception and a negative pregnancy test, Subject known to have been previously had COVID-19 must meet the following conditions: •Asymptomatic for at least 1 month before screening visit •Re-established on background immunosuppressants for at least 1 month prior to randomization

Exclusion Criteria

Recipient of multi-organ transplants, Other significant liver disease as per Investigator’s opinion, Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L), Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma, History of malignancy, unless subject has been considered to have fully recovered from malignancy since > 2 years, without any signs of relapse, History of diverticulitis, inflammatory bowel disease (IBD) or gastrointestinal perforation, Ongoing alcohol or illicit substance abuse, Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator’s opinion, Mental inability or reluctance that result in difficulties in understanding the meaning of study participation, Woman of childbearing potential who is unwilling/unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of trial drug, Woman with a positive pregnancy test or who is pregnant or breastfeeding, De novo or recurrent renal disease, if it is considered to be the predominant cause of the current graft dysfunction, Current or recent (within last 3 months) participation in another clinical drug trial, Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), SARS COV-2 (COVID-19), EBV, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections, based on polymerase chain reaction (PCR) testing, Ongoing serious infections as per Investigator’s opinion, History of recurrent serious infections requiring hospitalization, Signs of post-transplant lymphoproliferative disorder, Active tuberculosis (TB), Untreated latent TB (positive QuantiFERON-TB-Gold test, Chest X-ray), Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified