Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510615-29-00 | EU Trial (CTIS) Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Karolinska University Hospital | OTHER |
| Uppsala University Hospital | OTHER |
| Skane University Hospital | OTHER |
| The Swedish Research Council |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Standard of care (SOC) + tocilizumab (TCZ) | Active Comparator | SOC, as below + TCZ (162 mg every week, subcuataneous administration) |
|
| Arm B: SOC | No Intervention | Tacrolimus (target concentration 6 ±1 µg/L) + MPA (1.5-2 g/day as tolerated) + prednisolone (not less than 5 mg/day), all oral administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite risk prediction score iBox | Efficacy of the treatment regimen by assessing the iBox score | baseline and upto 24 months |
| Incidence of adverse and serious events related to TCZ treatment |
Not provided
Inclusion Criteria:
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
Epstein-Barr Virus (EBV) IgG-positive
For female participants of childbearing potential:
Subject known to have COVID-19 previously must meet all of the following conditions:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seema Baid-Agrawal, MD, FASN | Contact | +4631-342 10 00 | seema.baid-agrawal@vgregion.se | |
| Marie Felldin, MD, PhD | Contact | +4631-342 10 00 | marie.felldin@surgery.gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Seema Baid-Agrawal, MD, FASN | Transplant Center, Sahlgrenska University Hospital, Gothenburg, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario A Coruña | Not yet recruiting | A Coruña | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38519988 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
Not provided
Not provided
Not provided
| OTHER_GOV |
| Hospital del Mar | OTHER |
| Hospital Universitario Doctor Peset | OTHER |
| Complexo Hospitalario Universitario de A Coruña | OTHER |
| Hospital Universitario Marqués de Valdecilla | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Assessments of incidence of any side effects including infectious complications associated with TCZ therapy
| up to 25 months |
| Change in Donor-specific anti-HLA antibodies (DSA) | Change in DSA from baseline based on luminex assessments every 12 months | baseline and up to 36 months |
| 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 | baseline and up to 24 months |
| Changes in proteinuria | Assessed by urine albumin creatinine ratio (UACR) at baseline and every 12 months | baseline and up to 36 months |
| Renal function assessed by measured GFR (mGFR) | Changes from baseline in renal function as assessed by mGFR using iohexol clearance | baseline and up to 36 months |
| 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) | baseline and up to 36 months |
| Patient survival | Incidence of patient survival at 12, 24 and 36 months after start of treatment | up to 36 months |
| Death-censored graft survival | Incidence of death-censored graft survival at 12, 24 and 36 months after start of treatment | up to 36 months |
| Possible change in experienced transplant-specific well-being and symptom burden | Assessed using a validated self-reported questionnaires at baseline and every 12 months | upto 36 months |
| 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 | upto 36 months |
| Possible change in adherence to immunosuppressive medications | Assessed using a validated self-reported questionnaires at baseline and every 12 months | upto 36 months |
| Hospital del Mar | Active, not recruiting | Barcelona | Spain |
| Marqués de Valdecilla Research Institute | Not yet recruiting | Santander | Spain |
|
| Hospital Universitario Dr. Peset | Not yet recruiting | Valencia | Spain |
|
| Skåne University Hospital | Recruiting | Malmö | Skåne County | 214 28 | Sweden |
|
| Transplant Center, Sahlgrenska University Hospital | Recruiting | Gothenburg | Vastra Gotaland Regioin | Sweden |
|
| Karolinksa University Hospital | Recruiting | Stockholm | SE-141 86 | Sweden |
|
| Uppsala University Hospital | Recruiting | Uppsala | 751 85 | Sweden |
|