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Tocilizumab in chro...
Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)
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- Streichart, Lillian, 1983 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Felldin, Marie (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Ekberg, Jana, 1964 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Mjörnstedt, Lars, 1956 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Lindner, Per, 1956 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Lennerling, Annette, 1963 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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- Brocker, Verena (författare)
- Sahlgrens Univ Hosp, Dept Pathol, Gothenburg, Sweden.
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- Molne, Johan (författare)
- Sahlgrens Univ Hosp, Dept Pathol, Gothenburg, Sweden.
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- Holgersson, Jan (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för laboratoriemedicin,Department of Laboratory Medicine,Univ Gothenburg, Inst Biomed, Dept Lab Med, Gothenburg, Sweden.;Sahlgrens Univ Hosp, Dept Clin Immunol & Transfus Med, Gothenburg, Sweden.
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- Daenen, Kristien (författare)
- Sahlgrens Univ Hosp, Dept Nephrol, Gothenburg, Sweden.
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- Wennberg, Lars (författare)
- Karolinska Univ Hosp, Dept Transplantat Surg, Stockholm, Sweden.
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- Lorant, Tomas, 1975- (författare)
- Uppsala universitet,Transplantationskirurgi
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- Baid-Agrawal, Seema, 1966 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för kirurgi,Institute of Clinical Sciences, Department of Surgery,Univ Gothenburg, Sahlgrenska Univ Hosp, Transplant Inst, Inst Clin Sci,Sahlgrenska Acad, S-41345 Gothenburg, Sweden.
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(creator_code:org_t)
- BioMed Central (BMC), 2024
- 2024
- Engelska.
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Ingår i: TRIALS. - : BioMed Central (BMC). - 1745-6215. ; 25:1
- Relaterad länk:
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https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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Abstract
Ämnesord
Stäng
- BackgroundChronic active antibody-mediated rejection (caAMR) in kidney transplants is associated with irreversible tissue damage and a leading cause of graft loss in the long-term. However, the treatment for caAMR remains a challenge to date. Recently, tocilizumab, a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor, has shown promise in the treatment of caAMR. However, it has not been systematically investigated so far underscoring the need for randomized controlled studies in this area.MethodsThe INTERCEPT study is an investigator-driven randomized controlled open-label multi-center trial in kidney transplant recipients to assess the efficacy of tocilizumab in the treatment of biopsy-proven caAMR. A total of 50 recipients with biopsy-proven caAMR at least 12 months after transplantation will be randomized to receive either tocilizumab (n = 25) added to our standard of care (SOC) maintenance treatment or SOC alone (n = 25) for a period of 24 months. Patients will be followed for an additional 12 months after cessation of study medication. After the inclusion biopsies at baseline, protocol kidney graft biopsies will be performed at 12 and 24 months. The sample size calculation assumed a difference of 5 ml/year in slope of estimated glomerular filtration rate (eGFR) between the two groups for 80% power at an alpha of 0.05.The primary endpoint is the slope of eGFR at 24 months after start of treatment. The secondary endpoints include assessment of the following at 12, 24, and 36 months: composite risk score iBox, safety, evolution and characteristics of donor-specific antibodies (DSA), graft histology, proteinuria, kidney function assessed by measured GFR (mGFR), patient- and death-censored graft survival, and patient-reported outcomes that include transplant-specific well-being, adherence to immunosuppressive medications and perceived threat of the risk of graft rejection.MethodsThe INTERCEPT study is an investigator-driven randomized controlled open-label multi-center trial in kidney transplant recipients to assess the efficacy of tocilizumab in the treatment of biopsy-proven caAMR. A total of 50 recipients with biopsy-proven caAMR at least 12 months after transplantation will be randomized to receive either tocilizumab (n = 25) added to our standard of care (SOC) maintenance treatment or SOC alone (n = 25) for a period of 24 months. Patients will be followed for an additional 12 months after cessation of study medication. After the inclusion biopsies at baseline, protocol kidney graft biopsies will be performed at 12 and 24 months. The sample size calculation assumed a difference of 5 ml/year in slope of estimated glomerular filtration rate (eGFR) between the two groups for 80% power at an alpha of 0.05.The primary endpoint is the slope of eGFR at 24 months after start of treatment. The secondary endpoints include assessment of the following at 12, 24, and 36 months: composite risk score iBox, safety, evolution and characteristics of donor-specific antibodies (DSA), graft histology, proteinuria, kidney function assessed by measured GFR (mGFR), patient- and death-censored graft survival, and patient-reported outcomes that include transplant-specific well-being, adherence to immunosuppressive medications and perceived threat of the risk of graft rejection.DiscussionNo effective treatment exists for caAMR at present. Based on the hypothesis that inhibition of IL-6 receptor by tocilizumab will reduce antibody production and reduce antibody-mediated damage, our randomized trial has a potential to provide evidence for a novel treatment strategy for caAMR, therewith slowing the decline in graft function in the long-term.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Urologi och njurmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Urology and Nephrology (hsv//eng)
Nyckelord
- Kidney transplantation
- Chronic active antibody-mediated rejection
- Donor-specific antibody
- Interleukin-6
- Tocilizumab
- Treatment
- Kidney transplantation
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
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Streichart, Lill ...
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Felldin, Marie
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Ekberg, Jana, 19 ...
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Mjörnstedt, Lars ...
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Lindner, Per, 19 ...
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Lennerling, Anne ...
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Brocker, Verena
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Molne, Johan
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Holgersson, Jan
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Daenen, Kristien
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Wennberg, Lars
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Lorant, Tomas, 1 ...
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Baid-Agrawal, Se ...
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