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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04335578
Recruitment Status : Suspended (Study recruitment temporarily halted as a precautionary measure due to COVID-19 pandemic)
First Posted : April 6, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Allograft Injury Drug: UCB7858 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 2-Stage, Multicenter, Randomized, Placebo-Controlled Study to Evaluate Safety/Tolerability, Pharmacokinetics, and Efficacy of UCB7858 in Adult Kidney Transplant Recipients With Chronic Allograft Injury
Actual Study Start Date : October 21, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UCB7858 Cohorts
Subjects will be randomized to receive UCB7858 or Placebo in order to maintain the blinding. The dose for Stage 2 will be informed by DMC recommendation based on Stage 1 data.
Drug: UCB7858
Subjects will receive UCB7858 at pre-specified time-points.

Placebo Comparator: Placebo
Subjects randomized to this arm will receive matching Placebo to maintain the blinding.
Drug: Placebo
Subjects will receive matching placebo at pre-specified time-points to maintain the blinding.




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) (Stages 1 and 2) [ Time Frame: From Day 1 (Baseline) to the end of Safety Follow-up (Up to Day 505 for Stage 1 and Day 477 for Stage 2) ]
    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

  2. Absolute estimated Glomerular Filtration Rate (eGFR) value (Stage 2 only) [ Time Frame: From Day 1 (Baseline) to the end of Treatment Period for Stage 2 (up to Day 337) ]
    eGFR is estimated Glomerular Filtration Rate and analysed using Time as a continuous covariate in the model


Secondary Outcome Measures :
  1. Absolute estimated Glomerular Filtration Rate (eGFR) value (Stages 1 and 2, separately or combined, as appropriate) [ Time Frame: From Day 57 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) ]
    eGFR is estimated Glomerular Filtration Rate and analysed using (i) Time as a continuous covariate in the model and (ii) Time as a categorical covariate in the model

  2. Percent of Baseline eGFR value (Stages 1 and 2, separately or combined, as appropriate) [ Time Frame: From Day 57 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) ]
    eGFR is estimated Glomerular Filtration Rate and analysed using (i) Time as a continuous covariate in the model and (ii) Time as a categorical covariate in the model

  3. Change from Baseline in PCR (Stages 1 and 2, separately or combined, as appropriate) [ Time Frame: From Day 57 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) ]
    PCR is Protein Creatinine Ratio measured in urine and analysed using (i) Time as a continuous covariate in the model and (ii) Time as a categorical covariate in the model

  4. Time to Graft Failure (Stages 1 and 2, separately or combined, as appropriate) [ Time Frame: From Day 1 (Baseline) to the end of Treatment Period (Up to Day 365 for Stage 1 and Day 337 for Stage 2) ]
    Graft Failure defined as an eGFR of <=15 mL/min/1.73 m2 and time to Graft Failure analysed using Cox proportional hazards regression

  5. Serum concentration of UCB7858 (Stages 1 and 2) [ Time Frame: From Day 1 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) ]
    Serum concentration of the drug UCB7858 during Stage 1 and Stage 2.

  6. Urine concentration of UCB7858 (Stages 1 and 2) [ Time Frame: From Day 1 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) ]
    Urine concentration of the drug UCB7858 during Stage 1 and Stage 2.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 m2 for a period of 6 months up to screening
  • Stable standard of care concomitant medication for 3 months prior to screening
  • Subject 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
  • Subject who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
  • Subject 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 IMP
  • Subject has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer
  • Subject has a history of wound healing complications
  • Subject has taken concomitant medication of sirolimus or everolimus within 3 months of screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335578


Locations
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Australia
Cai001 401
Adelaide, Australia
Cai001 403
Nedlands, Australia
Cai001 402
Randwick, Australia
Belgium
Cai001 101
Leuven, Belgium
Germany
Cai001 201
Berlin, Germany
Spain
Cai001 301
Barcelona, Spain
Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Principal Investigator: UCB Cares 001 844 599 2273 (UCB)
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT04335578    
Other Study ID Numbers: CAI001
2017-004807-31 ( EudraCT Number )
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Chronic Allograft Injury
UCB7858
Kidney transplantation
CAI
Additional relevant MeSH terms:
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Wounds and Injuries