Male or female patients with a diagnosis of C3G or primary IC˗MPGN and planning to undergo kidney transplantation because of the disease.
Conditions
Brief summary
Occurrence of clinically significant recurrent disease within 2 years post–kidney transplantation, defined by both histological evidence from the biopsy and clinical evidence of recurrence (≥1 of the following: increase in urinary protein-to-creatinine ratio, decrease in eGFR, or hematuria), judged clinically significant by the Investigator in the absence of alternative causes
Detailed description
Time from kidney transplantation surgery to onset of clinically significant recurrence of C3G or primary IC-MPGN, Histological evidence of recurrent disease within 2 years of kidney transplantation, based on the histopathological assessment of a kidney biopsy at the study center, Time from kidney transplantation surgery to histological evidence of recurrent disease, The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of clinically significant recurrent disease within 2 years post–kidney transplantation, defined by both histological evidence from the biopsy and clinical evidence of recurrence (≥1 of the following: increase in urinary protein-to-creatinine ratio, decrease in eGFR, or hematuria), judged clinically significant by the Investigator in the absence of alternative causes | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from kidney transplantation surgery to onset of clinically significant recurrence of C3G or primary IC-MPGN, Histological evidence of recurrent disease within 2 years of kidney transplantation, based on the histopathological assessment of a kidney biopsy at the study center, Time from kidney transplantation surgery to histological evidence of recurrent disease, The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) | — |