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

Recruiting

• Conditions: focal segmental glomerulosclerosis; nephrotic syndrome; 10029149

• Registration Number: NL-OMON48161
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main outcome is the proportion of assay results that correctly reflect clinical<br /><br>outcome of r-FSGS (podocyte damage in r-FSGS; no podocyte damage in non r-FSGS).<br /><br>Main outcome will be based on podocyte damage according to chosen assays to<br /><br>demonstate podocyte damage caused by FSGS patient plasma. Results will be<br /><br>linked to the clinical data of the patients in the pre-specified groups of<br /><br>r-FSGS and non r-FSGS. Podocyte damage caused by FSGS patient plasma will be<br /><br>assessed in comparison with control plasma (from kidney donors).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures:<br /><br>1. the response of induced patient podocytes to blood plasma of the same<br /><br>patient (positive control);<br /><br>2. the response of induced patient and donor podocytes to blood plasma of the<br /><br>kidney donor (negative controls);<br /><br>3. if the primary outcome is favorable, the response of other donor and patient<br /><br>podocytes to FSGS patient plasma will be evaluated.</p><br>