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Table 3 Study endpoints

From: Tocilizumab in chronic active antibody-mediated rejection: rationale and protocol of an in-progress randomized controlled open-label multi-center trial (INTERCEPT study)

Primary endpoint: Mean rate of change in eGFR (eGFR slope) from baseline to 24 months after start of treatment

Secondary endpoints:

1. Change from baseline in mean iBox risk prediction score at 12 and 24 months

2. Safety: incidence, nature and severity of adverse events (AE) during 24 months of treatment period

3. Evolution of DSA (MFI) at baseline, 12, 24 and 36 months

4. Histologic changes in biopsy at 12 and 24 months

5. Changes in proteinuria (UACR) at 12, 24 and 36 months

6. Changes in renal function at 12, 24 and 36 months, assessed by mGFR using iohexol clearance

7. Changes in renal function at 12 and 36 months, assessed by eGFR

8. Incidence of patient survival at 12, 24 and 36 months

9. Incidence of death-censored graft survival 12, 24 and 36 months

10. Possible changes of experienced transplant-specific well-being, symptom burden, perceived threat of the risk of graft rejection and adherence to immunosuppressive medications at 12, 24 and 36 months after start of treatment

  1. DSA Donor-specific antibodies, eGFR Estimated glomerular filtration rate, MFI Mean fluorescence intensity, UACR Urine albumin:creatinine ratio
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ISSN: 1745-6215