A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04335578|
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : October 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Chronic Allograft Injury||Drug: Zampilimab Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This is an Investigator-blind and participant-blind study.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Placebo-Controlled Investigator-Blind, Participant-Blind Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury|
|Actual Study Start Date :||October 21, 2019|
|Estimated Primary Completion Date :||May 2025|
|Estimated Study Completion Date :||May 2025|
Experimental: Zampilimab Cohorts
Participants will be randomized to receive zampilimab (UCB7858).
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
Other Name: UCB7858
Placebo Comparator: Placebo
Participants randomized to this arm will receive matching Placebo.
Participants will receive matching placebo at pre-specified time-points.
- Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) ]A treatment-emergent adverse event (TEAE) is defined as any event not present prior to the administration of investigational medicinal product (IMP) or any unresolved event already present before administration of IMP that worsens in intensity following exposure to the treatment.
- Serum concentration of zampilimab [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) ]Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
- Urine concentration of zampilimab [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) ]Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335578
|Contact: UCB Cares||001 844 599 2273||UCBCares@ucb.com|
|London, United Kingdom|
|Principal Investigator:||UCB Cares||001 844 599 2273 (UCB)|