NCT03444103

A Pilot Trial of Clazakizumab in Late ABMR

Completed Phase 2 Last updated 9 September 2020

What this trial tests

Phase 2 trial testing Clazakizumab / Clazakizumab in Antibody-mediated Rejection in 20 participants. Completed in 30 June 2020.

Timeline

16 January 2018

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	Medical University of Vienna
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	16 January 2018
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	2 locations across Austria, Germany

Drugs / interventions tested

• Clazakizumab / Clazakizumab — full drug profile →
• Placebo / Clazakizumab — full drug profile →

Conditions studied

• Antibody-mediated Rejection — all drugs for Antibody-mediated Rejection →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 100, any sex, with Antibody-mediated Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This bi-center study (Medical University of Vienna \& Charité Berlin) is an investigator-driven pilot trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy (preliminary assessment) of humanized anti-IL-6 monoclonal antibody clazakizumab in kidney transplant recipients with late antibody-mediated rejection (ABMR). The study is designed as a phase 2 trial and has two subsequent sub-parts, a randomized placebo-controlled trial (part A) of 12 weeks, where recipients are allocated to receive either anti-IL-6 antibody clazakizumab (n=10) or placebo (n=10), followed by an open-label prospective study, where all 20 study patients will receive clazakizumab for a period of 40 weeks. Study protocol biopsies will be performed at the end of part A and part B.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Clinical Trial of Anti-IL-6 Antibody Clazakizumab in Late Antibody-Mediated Kidney Transplant Rejection.
   Doberer K, Duerr M, Halloran PF, Eskandary F, et al · · 2021 · cited 137× · PMID 33443079 · DOI 10.1681/asn.2020071106
2. The therapeutic challenge of late antibody-mediated kidney allograft rejection.
   Böhmig GA, Eskandary F, Doberer K, Halloran PF. · · 2019 · cited 87× · PMID 30955215 · DOI 10.1111/tri.13436
3. Role of Macrophages and Related Cytokines in Kidney Disease.
   Cantero-Navarro E, Rayego-Mateos S, Orejudo M, Tejedor-Santamaria L, et al · · 2021 · cited 79× · PMID 34307414 · DOI 10.3389/fmed.2021.688060
4. Tackling Chronic Kidney Transplant Rejection: Challenges and Promises.
   Lai X, Zheng X, Mathew JM, Gallon L, et al · · 2021 · cited 66× · PMID 34093552 · DOI 10.3389/fimmu.2021.661643
5. IL-6 Directed Therapy in Transplantation.
   Miller CL, Madsen JC. · · 2021 · cited 50× · PMID 34099967 · DOI 10.1007/s40472-021-00331-4
6. Clazakizumab in late antibody-mediated rejection: study protocol of a randomized controlled pilot trial.
   Eskandary F, Dürr M, Budde K, Doberer K, et al · · 2019 · cited 45× · PMID 30635033 · DOI 10.1186/s13063-018-3158-6
7. Clazakizumab for the treatment of chronic active antibody-mediated rejection (AMR) in kidney transplant recipients: Phase 3 IMAGINE study rationale and design.
   Nickerson PW, Böhmig GA, Chadban S, Kumar D, et al · · 2022 · cited 27× · PMID 36550562 · DOI 10.1186/s13063-022-06897-3
8. Chronic Rejection After Kidney Transplantation.
   Diebold M, Mayer KA, Hidalgo L, Kozakowski N, et al · · 2025 · cited 20× · PMID 39192468 · DOI 10.1097/tp.0000000000005187