Study of safety and efficacy of CFZ533 in kidney transplant patients

Phase 1

• Conditions: Renal transplantation; MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-003607-22-FR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-19
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

1.Male or female patient = 18 years old.
2. Up to date vaccination
3.Recipients of a primary kidney transplant from a brain-death donor (DBD), living unrelated or non-HLA identical living related donor (cohort1).
4.Recipients of a kidney with a cold ischemia time (CIT) < 24 hours (cohort 1)
5. Recipients of a primary graft received 6 to 24 months prior enrollment, on a regimen
containing Tac+MMF±CS (Cohort 2)
6.Patients with an actual eGFR = 45 mL/min/1.73m2 (Cohort 2)
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 295
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Multi-organ transplant recipients or prior kidney transplant (cohort 1 and 2)
2.Pregnant or nursing women (cohort 1 and 2)
3.Women of child bearing potential unless using highly effective methods of contraception during dosing and 12 weeks after study medication has been stopped (cohort 1 and 2)
4. Recipients of an organ from a donor after cardiac death (DCD) (cohort 1).
5. Recipient of an organ from an HLA identical living related donor (cohort 1).
6. Recipients of kidneys from donors who are older than 65 years (cohort 1).
7.Patients at high immunological risk for rejection (cohort 1)
8.DSA within 12 weeks prior enrollment (cohort 2)
9. Ongoing rejection or rejection that required treatment within 12 weeks prior enrollment (cohort 2)
10. Severe humoral and/or cellular rejection (BANFF = IIb) before enrollment (cohort 2)

Study & Design

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