A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

Chronic Allograft Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04335578
• Other study ID #: CAI001
• Secondary ID: 2017-004807-31
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 21, 2019
• Est. completion date: May 4, 2022

Study information

• Verified date: September 2022
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Allograft Injury
• Wounds and Injuries

Intervention

Drug:
• Zampilimab
Participants will receive zampilimab (UCB7858) at pre-specified time-points.
• Placebo
Participants will receive matching placebo (PBO) at pre-specified time-points.

Locations

Country	Name	City	State
Australia	Cai001 403	Nedlands
Belgium	Cai001 101	Leuven
Spain	Cai001 301	Barcelona
Spain	Cai001 302	Hospitalet de Llobregat
United Kingdom	Cai001 501	London

Sponsors (1)

Lead Sponsor	Collaborator
UCB Biopharma SRL

Countries where clinical trial is conducted

Australia,  Belgium,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)	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.	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary	Serum concentration of zampilimab	Serum concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)
Secondary	Urine concentration of zampilimab	Urine concentration of the drug zampilimab from Baseline to the end of the last Safety Follow-up Visit	From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680)