NCT05875454

Brief Summary

  • To assess the density and ultrastructural morphology of podocytes in different glomerular diseases.
  • Correlate the podocyte density and ultrastuctural morphology with laboratory data, the histopathological diagnosis and the active and chronic histopathological lesions in the biopsy.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

2.3 years

First QC Date

April 30, 2023

Last Update Submit

June 9, 2023

Conditions

Glomerular Disease

Outcome Measures

Primary Outcomes (1)

  • assessment of podocytes integrity in different glomerular disaeses.

    Assessment of podocytes density which will be detected by immunohistochemical expression of WT-1 in different glomerular diseases. Correletion between the podocytes density with laboratory data of the cases and the histopathological diagnosis.

    14 months

Interventions

Histopathological examination of tru-cut needle biopsyDIAGNOSTIC_TEST

Renal biopsies fixed in formalin from patients with suspected medical renal disease will be processed and examined for histopathological diagnosis.

Eligibility Criteria

Age10 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients suspected to have medical renal disease.

You may qualify if:

  • Patients undergoing renal biopsy and diagnosed as glomerular disease.

You may not qualify if:

  • Patients diagnosed as tubule-interstitial diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Guo JK, Menke AL, Gubler MC, Clarke AR, Harrison D, Hammes A, Hastie ND, Schedl A. WT1 is a key regulator of podocyte function: reduced expression levels cause crescentic glomerulonephritis and mesangial sclerosis. Hum Mol Genet. 2002 Mar 15;11(6):651-9. doi: 10.1093/hmg/11.6.651.

    PMID: 11912180BACKGROUND

  • Barutta F, Bellini S, Gruden G. Mechanisms of podocyte injury and implications for diabetic nephropathy. Clin Sci (Lond). 2022 Apr 14;136(7):493-520. doi: 10.1042/CS20210625.

    PMID: 35415751BACKGROUND

  • Sever S. Role of actin cytoskeleton in podocytes. Pediatr Nephrol. 2021 Sep;36(9):2607-2614. doi: 10.1007/s00467-020-04812-z. Epub 2020 Nov 13.

    PMID: 33188449BACKGROUND

  • Kravets I, Mallipattu SK. The Role of Podocytes and Podocyte-Associated Biomarkers in Diagnosis and Treatment of Diabetic Kidney Disease. J Endocr Soc. 2020 Mar 5;4(4):bvaa029. doi: 10.1210/jendso/bvaa029. eCollection 2020 Apr 1.

    PMID: 32232184BACKGROUND

  • Nagata M. Podocyte injury and its consequences. Kidney Int. 2016 Jun;89(6):1221-30. doi: 10.1016/j.kint.2016.01.012. Epub 2016 Mar 19.

    PMID: 27165817BACKGROUND

  • Dong L, Pietsch S, Englert C. Towards an understanding of kidney diseases associated with WT1 mutations. Kidney Int. 2015 Oct;88(4):684-90. doi: 10.1038/ki.2015.198. Epub 2015 Jul 8.

    PMID: 26154924BACKGROUND

  • Lal MA, Patrakka J. Understanding Podocyte Biology to Develop Novel Kidney Therapeutics. Front Endocrinol (Lausanne). 2018 Jul 23;9:409. doi: 10.3389/fendo.2018.00409. eCollection 2018.

    PMID: 30083135BACKGROUND

  • Mathieson PW. The podocyte as a target for therapies--new and old. Nat Rev Nephrol. 2011 Nov 1;8(1):52-6. doi: 10.1038/nrneph.2011.171.

    PMID: 22045242BACKGROUND

  • Muller-Deile J, Schiffer M. Podocyte directed therapy of nephrotic syndrome-can we bring the inside out? Pediatr Nephrol. 2016 Mar;31(3):393-405. doi: 10.1007/s00467-015-3116-4. Epub 2015 May 5.

    PMID: 25939817BACKGROUND

  • Testagrossa L, Azevedo Neto R, Resende A, Woronik V, Malheiros D. Immunohistochemical expression of podocyte markers in the variants of focal segmental glomerulosclerosis. Nephrol Dial Transplant. 2013 Jan;28(1):91-8. doi: 10.1093/ndt/gfs325. Epub 2012 Aug 1.

    PMID: 22859792BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Renal biopsies fixed in formalin from patients with suspected medical renal disease will be processed and examined for histopathological diagnosis.

Central Study Contacts

Aya Salah, administrator

CONTACT

01095538980ayaasalah23@gmail.com

Ghada Hosney, lecturer

CONTACT

01062778691Ghada_h@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 25, 2023

Study Start

July 1, 2023

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

June 12, 2023

Record last verified: 2023-06