Study to test treatment with two types of cells for influencing the immune system in kidney transplant patients

Phase 1

• Conditions: Kidney transplantation.; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2018-003142-16-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-12
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

? Patient has provided written informed consent.
? Patient is 18 years or older.
? Patient is a planned recipient of a living donor kidney transplant.
? Patient is a planned recipient of an ABO-compatible kidney graft.
? Patient is a planned recipient of a kidney graft from a donor that is not HLA-identical.
? Patient is negative for DSA.
? WOCBP must have a negative pregnancy test at inclusion.
? WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the study in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Patient is EBV-negative on serology.
Patient is HIV-positive or suffering from chronic viral hepatitis.
Patient is CMV-negative and receiving a kidney from a CMV-positive donor.
Positive T-cell lymphocytotoxic cross match.
Patient with prior kidney transplant or non-renal solid organ transplant.
Patient has a known contraindication to any of the protocol-specified treatments.
Patient had been diagnosed with a malignancy within 5 years prior to study entry, excluding non-metastatic basal or squamous cell carcinoma of the skin.
Female patients who are breast-feeding.
Female patients with a positive pregnancy test

Study & Design

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