CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Felzartamab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05021484
NCT05021484Phase 2Completed
CompareCT.gov

Safety, Tolerability and Efficacy of Monoclonal CD38 Antibody Felzartamab in Late Antibody-Mediated Renal Allograft Rejection - A Phase 2 Pilot Trial

Farsad Eskandary·interventional·Posted Aug 25, 2021·Updated Apr 18, 2024

In Brief

A Phase 2 clinical trial evaluating Felzartamab and Placebo for Antibody-mediated Rejection. Completed, enrolled 22 participants across 2 sites in 2 countries.

Detailed Summary

This prospective trial will assess the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and efficacy of the fully human CD38 monoclonal antibody felzartamab in kidney transplant recipients with late active or chronic-active ABMR. The study is designed as a randomized, controlled, double-blind pilot phase 2 trial. Participants will be randomized to receive either felzartamab or placebo for a period of six months, and then followed for another six months. After six and twelve months, study participants will be subjected to follow-up allograft biopsies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntibody-mediated Rejection
CountriesAustria, Germany
CollaboratorsCharite University, Berlin, Germany, University of Alberta, Biogen

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 25, 2021
Enrollment StartOct 6, 2021
Primary CompletionMar 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 4.9 years ago

Interventions

Felzartamabdrug

Intravenous infusion in regular intervals over 6 months

Placebodrug

Intravenous infusion in regular intervals over 6 months