Chronic Allograft Injury MedDRA version: 20.1 Level: PT Classification code 10063209 Term: Chronic allograft nephropathy System Organ Class: 10021428 - Immune system disorders
Conditions
Interventions
Product Name: Zampilimab
Product Code: UCB7858
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ZAMPILIMAB
Current Sponsor code: UCB7858
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Functioning living or deceased donor allograft >=1 year posttransplantation -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 posttransplant, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
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 antibodymediated 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI);Secondary Objective: Evaluate the pharmacokinetics (PK) of Zampilimab when administered as repeat doses intravenous (iv) in kidney transplant recipients with CAI;Primary end point(s): Incidence of treatment-emergent adverse events (TEAEs) ;Timepoint(s) of evaluation of this end point: From Day 1 (Baseline) to the end of Safety Follow-up Visit (up to Day 680) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Serum concentration of zampilimab 2. Urine concentration of zampilimab;Timepoint(s) of evaluation of this end point: 1.- 9. From Day 1 (Baseline) to the end of Treatment Period for Stage 1 (up to Day 365) and from Day 1 to the end of Treatment Period for Stage 2 (up to Day 337) | — |
Countries
Belgium, Germany, Spain, United Kingdom
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed