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Antibody-mediated RejectionPhase 3INTERCEPTNCT04561986

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

A Phase 3 study testing Tocilizumab in people with Antibody-mediated Rejection, run by Vastra Gotaland Region at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Antibody-mediated Rejection
What is being tested?
Tocilizumab
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
6 sitesin 2 countries
Study dates
1 Feb 2022to Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject has given their written informed consent to participate in the study
  • Recipient of living donor or deceased donor kidney transplant
  • Age ≥18 years
  • At least 6 months post-transplantation at randomization
  • Biopsy-proven diagnosis of late active or chronic active ABMR (≥ 6 months after transplantation) according to the Banff 2022 criteria in index biopsy
  • eGFR ≥20 ml/min/1.73 m2
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  • Epstein-Barr Virus (EBV) IgG-positive
  • For female participants of childbearing potential:
  • use of adequate contraception and a negative pregnancy test
  • Subject known to have COVID-19 previously must meet all of the following conditions:
  • Asymptomatic for at least 1 month before the start of screening
  • Re-established on background immunosuppressants for at least 1 month prior to the randomization

Who cannot join

  • Recipient of multi-organ transplants
  • De novo or recurrent renal disease that is considered to be the predominant cause of the current graft dysfunction
  • Active viral infections such as BK virus (BKV), cytomegalovirus (CMV), EBV, COVID-19, hepatitis C virus (HCV) or hepatitis B virus (HBV) infections based on polymerase chain reaction (PCR) testing
  • Ongoing serious infections as per Investigator's opinion
  • History of recurrent infections requiring hospitalization
  • Active tuberculosis (TB)
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  • Latent untreatedTB (positive QuantiFERON-TB-Gold test, Chest X-ray)
  • Abnormal liver function tests alanine transaminase (ALT), aspartate transaminase (AST), bilirubin > 1.5 x upper limit of normal)
  • Other significant liver disease as per Investigator's opinion
  • Neutropenia (<2 x109/L) or thrombocytopenia (<100 x109/L)
  • Signs of post-transplant lymphoproliferative disorder
  • Signs of malignancy. Exceptions are basal cell carcinoma/squamous cell carcinoma or non-malignant melanoma
  • History of malignancy, unless subject has been considered to have fully recovered from malignancy since > 2 years, without any signs of relapse
  • History of diverticulitis, inflammatory bowel disease or gastrointestinal perforation
  • Ongoing alcohol or illicit substance abuse
  • Serious medical or psychiatric illness likely to interfere with participation in the study as per Investigator's opinion
  • Mental inability or reluctance that results in difficulties in understanding the meaning of study participation
  • Woman of childbearing potential who is unwilling/unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
  • Woman with a positive pregnancy test or who is pregnant or breastfeeding
  • Current or recent (within last 3 months) participation in another clinical drug trial

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Spain3 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Dr. Peset

    Valencia

Other trials in Spain

Sweden3 sites

  • Transplant Center, Sahlgrenska University Hospital

    Gothenburg, Vastra Gotaland Regioin

  • Karolinksa University Hospital

    Stockholm, Stockholm County, SE-141 86

  • Uppsala University Hospital

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

About this study

Official title: A Randomized Controlled Open-label Multi-center Study to Assess the Efficacy of TCZ in Treatment of Late/Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients

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.

Being tested
Tocilizumab
Keywords
Kidney transplant, Chronic rejection, Antibody-mediated rejection, Graft function, Donor specific antibodies (DSA), Transplant-specific well-being, Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RoActemra

    Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor

Study groups in NCT04561986
Study groupRoleWhat they receive
Arm A: Standard of care (SOC) + tocilizumab (TCZ)Active comparatorSOC, as below + TCZ (162 mg every week, subcuataneous administration)
Receives: Drug: Tocilizumab
Arm B: SOCNo interventionTacrolimus (target concentration 6 ±1 µg/L) + MPA (1.5-2 g/day as tolerated) + prednisolone (not less than 5 mg/day), all oral administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in eGFR at 24 months

    Comparison of eGFR decline (eGFR slope) from baseline at 24 months after start of treatment in the two arms. The eGFR will be assessed by measured creatinine values using MDRD formula in mL/min/1.73m^2. MDRD formula is based on age, sex, ethnicity, and serum creatinine (in mg/dl) and eGFR values are calculated as follows: GFR in mL/min per 1.73 m^2 = 175 x Serum Cr^1.154 x age^-0.203 x 1.212 (if patient is black) x 0.742 (if female).

    Measured: Baseline and 24 months

Secondary outcomes (12)

  1. Composite risk prediction score iBox

    Efficacy of the treatment regimen by assessing the iBox score

    Measured: baseline and upto 24 months

  2. Incidence of adverse and serious events related to TCZ treatment

    Assessments of incidence of any side effects including infectious complications associated with TCZ therapy

    Measured: up to 25 months

  3. Change in Donor-specific anti-HLA antibodies (DSA)

    Change in DSA from baseline based on luminex assessments every 12 months

    Measured: baseline and up to 36 months

  4. Histologic changes in protocol biopsy

    Histologic changes at 12 and 24 months will be compared with those in the baseline biopsies. If the criteria for active AMR are no longer fulfilled in the follow-up biopsies, response to therapy is assumed. The response will be assessed as a yes/no categorical variable. In all biopsies, which still meet the required criteria for active AMR, means of individual Banff lesion scores will be compared between the baseline biopsy and the 12- and 24-months biopsies

    Measured: baseline and up to 24 months

  5. Changes in proteinuria

    Assessed by urine albumin creatinine ratio (UACR) at baseline and every 12 months

    Measured: baseline and up to 36 months

  6. Renal function assessed by measured GFR (mGFR)

    Changes from baseline in renal function as assessed by mGFR using iohexol clearance

    Measured: baseline and up to 36 months

  7. Renal function assessed by eGFR

    Changes from baseline in renal function at 12 and 36 months after start of treatment, as assessed by eGFR (CKD-EPI)

    Measured: baseline and up to 36 months

  8. Patient survival

    Incidence of patient survival at 12, 24 and 36 months after start of treatment

    Measured: up to 36 months

  9. Death-censored graft survival

    Incidence of death-censored graft survival at 12, 24 and 36 months after start of treatment

    Measured: up to 36 months

  10. Possible change in experienced transplant-specific well-being and symptom burden

    Assessed using a validated self-reported questionnaires at baseline and every 12 months

    Measured: upto 36 months

  11. Possible change in experienced perceived threat of the risk of graft rejection

    Assessed using a validated self-reported questionnaires at baseline and every 12 months

    Measured: upto 36 months

  12. Possible change in adherence to immunosuppressive medications

    Assessed using a validated self-reported questionnaires at baseline and every 12 months

    Measured: upto 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2020
  2. Study start1 Feb 2022
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04561986
Sponsor's protocol ID
2019-004302-10
Other IDs
2024-510615-29-00, 2019
Acronym
INTERCEPT
Status last verified
Aug 2026
First submitted
3 Sep 2020
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Streichart L, Felldin M, Ekberg J, Mjornstedt L, Lindner P, Lennerling A, Brocker V, Molne J, Holgersson J, Daenen K, Wennberg L, Lorant T, Baid-Agrawal S. Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study). Trials. 2024 Mar 22;25(1):213. doi: 10.1186/s13063-024-08020-0.

    PubMed 38519988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tocilizumab in people with Antibody-mediated Rejection, run by Vastra Gotaland Region at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in eGFR at 24 months (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04561986, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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