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