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The application of induced pluripotent stem cells to predict return of the same kidney disease after transplantation.

The application of induced pluripotent stem cells to predict return of the same kidney disease after transplantation. - A cross-match to predict FSGS recurrence after kidney transplantation.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48161
Enrollment
10
Registered
2019-08-22
Start date
2019-10-28
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

focal segmental glomerulosclerosis nephrotic syndrome

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)