Clinical trial NCT04335578: A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Chronic Allograft Injury
Keywords: Chronic Allograft Injury
UCB7858
Kidney transplantation
CAI
zampilimab
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2020-04-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 allograft injury (CAI).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary outcomes:
measure: Serum concentration of zampilimab
timeFrame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
measure: Urine concentration of zampilimab
timeFrame: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Other outcomes:
Locations:
city: Nedlands
country: Australia
facility: Cai001 403
city: Leuven
country: Belgium
facility: Cai001 101
city: Barcelona
country: Spain
facility: Cai001 301
city: Hospitalet de Llobregat
country: Spain
facility: Cai001 302
city: London
country: United Kingdom
facility: Cai001 501
Study officials:
affiliation: 001 844 599 2273
name: UCB Cares
role: PRINCIPAL_INVESTIGATOR
References: