Status:
TERMINATED
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Chronic Allograft Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic ...
Eligibility Criteria
Inclusion
- Functioning living or deceased donor allograft \>=1 year post-transplantation
- Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (\>=25% IF/TA)
- Progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (eGFR) decline of ≥3 mL/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart)
- An eGFR \>=30 mL/min/1.73 m\^2 for a period of 6 months up to screening
- Stable standard of care concomitant medication for 3 months prior to screening
- Participant is male or female, \>=18 years of age
Exclusion
- Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients)
- Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI)
- Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI
- Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI
- Proteinuria ≥1500 mg/g at screening
- Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
- Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP)
- Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing
- Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04335578
Start Date
October 21 2019
End Date
May 4 2022
Last Update
September 21 2022
Active Locations (5)
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1
Cai001 403
Nedlands, Australia
2
Cai001 101
Leuven, Belgium
3
Cai001 301
Barcelona, Spain
4
Cai001 302
L'Hospitalet de Llobregat, Spain