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TocIlizumab in Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

Study acronym: INTERCEPT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 2027 → Jun 2028
See other at-risk trials from Vastra Gotaland Region

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoingv7 Show 5 more changesShow less
    • Primary completion pushed from Dec 2027 to Jun 2028
    • Study completion pushed from Dec 2028 to Jun 2029
    • Study sites: 8 to 6
    • Collaborators: 8 to 6
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Oct 2026 to Dec 2027v6 Show 7 more changesShow less
    • Study sites: 4 to 8
    • Study completion date: Dec 2027 to Dec 2028
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 1 of 12 entries
    • Collaborators: 4 to 8
    • Publications: details revised at 1 of 1 entry
    • Study title expanded, about 1 word
  3. Primary completion date: Oct 2025 to Oct 2026v5 Show 5 more changesShow less
    • Study sites: 3 to 4
    • Study completion date: Dec 2026 to Dec 2027
    • Secondary endpoints: 11 to 12
    • Collaborators: 3 to 4
    • Eligibility criteria shortened, about 1 word
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 11, 2021 to Feb 1, 2022
    • Site details revised at 3 of 3 sites
    v4
  5. Start date: May 2021 to Oct 11, 2021
    • Primary completion date: May 2025 to Oct 2025
    • Study completion date: Sep 2026 to Dec 2026
    v3
  6. Phase: Phase 4 to Phase 3v2 Show 7 more changesShow less
    • Start date: Jan 2021 to May 2021
    • Enrollment target: 64 to 50
    • Study sites: 1 to 3
    • Primary completion date: Jan 2025 to May 2025
    • Study completion date: Mar 2026 to Sep 2026
    • Eligibility criteria shortened, about 53 words
    • Collaborators: 1 to 3
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This multi-center study is an investigator-driven randomized controlled parallel group open-label clinical trial designed to evaluate the efficacy of addition of anti-IL-6 antibody tocilizumab (TCZ) to the standard of care (SOC) treatment as compared to the SOC alone in reducing the decline of graft function in kidney transplant recipients with late or chronic antibody-mediated rejection (AMR). A total of 50 recipients will be allocated to receive either TCZ (n=25) added to the standard of care (SOC) or SOC alone (n=25) for a period of 24 months. Patients will be followed for an additional 12 months. Protocol kidney graft biopsies will be performed at 12 and 24 months. The primary outcome is the mean rate of change in graft function as assessed by estimated glomerular filtration rate (eGFR) slope from baseline to 24 months after start of treatment.
Trial Details
NCT Number NCT04561986
Lead Sponsor Vastra Gotaland Region
Collaborators: Karolinska University Hospital, Uppsala University Hospital, The Swedish Research Council, Hospital del Mar, Hospital Universitario Doctor Peset, Complexo Hospitalario Universitario de A Coruña
Conditions
(from sponsor)		 Antibody-mediated Rejection
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov