focal segmental glomerulosclerosis nephrotic syndrome
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Population: 1. Adult patients (18 years or older) with diagnosis of FSGS in the native kidneys, and known outcome after kidney transplantation (recurrent FSGS or non-recurrent FSGS). 2. Living persons who have previously donated a kidney to patients specified under 1.;Inclusion criteria 1. Established outcome after kidney transplantation (recurrence or non-recurrence of FSGS); 2. Living kidney donation; 3. Donor available for participation in the study
Exclusion criteria
Exclusion criteria: 1. Follow-up after transplantation too short to rule out development of late FSGS recurrence (less than one year); 2. Unknown histological diagnosis in the native kidney; 3. No communication between patient and donor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome is the proportion of assay results that correctly reflect clinical outcome of r-FSGS (podocyte damage in r-FSGS; no podocyte damage in non r-FSGS). Main outcome will be based on podocyte damage according to chosen assays to demonstate podocyte damage caused by FSGS patient plasma. Results will be linked to the clinical data of the patients in the pre-specified groups of r-FSGS and non r-FSGS. Podocyte damage caused by FSGS patient plasma will be assessed in comparison with control plasma (from kidney donors). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: 1. the response of induced patient podocytes to blood plasma of the same patient (positive control); 2. the response of induced patient and donor podocytes to blood plasma of the kidney donor (negative controls); 3. if the primary outcome is favorable, the response of other donor and patient podocytes to FSGS patient plasma will be evaluated. | — |
Countries
Netherlands