A Study to Evaluate Safety Tolerability Pharmacokinetics and Efficacy of UCB7858 in Adult Kidney Transplant Recipients With Chronic Allograft Injury

  • STATUS
    Recruiting
  • End date
    Oct 19, 2023
  • participants needed
    177
  • sponsor
    UCB Biopharma SRL
Updated on 19 August 2021

Summary

The main purpose of Stage 1 in this study is to investigate the safety and tolerability of UCB7858 in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI) and to determine the dose level for Stage 2. The main purpose of Stage 2 is to further investigate the safety, tolerability, and efficacy of repeat dosing with UCB7858 in kidney transplant recipients with deteriorating kidney function associated with CAI.

Details
Condition Chronic Allograft Injury
Treatment Placebo, UCB7858, Zampilimab
Clinical Study IdentifierNCT04335578
SponsorUCB Biopharma SRL
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Functioning 1st donor allograft >=1 year post-transplantation
Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (>=25% IF/TA)
Progressive decline in kidney function defined as estimated glomerular filtration rate (eGFR) decline >=5% during the 9 months prior to screening
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 dual kidney transplant recipients, and/or corneal transplant recipients)
Screening biopsy shows evidence of significant antibody-mediated rejection
Screening biopsy shows evidence of T cell-mediated rejection classified Banff Grade >=I
Screening biopsy shows evidence of de novo or recurrent glomerular disease
Screening biopsy shows severe transplant glomerulopathy lesions defined as chronic glomerulopathy (cg) score of 3
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
Participant has a history of wound healing complications
Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
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