Renal Biopsy Unexplained Elevated Serum Creatinine

NCT03586531 | Completed

• 1 other identifier: RBUESCAUH
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Patients presented with unexplained elevated serum creatinine including vast varieties of acute or chronic kidney disease. Renal biopsy may include acute and chronic interstitial nephritis, glomerulosclerosis and tubular atrophy, acute tubular necrosis, rapidly progressive glomerulonephritis, granulomatous glomerulonephritis, monoclonal gammopathy, myeloma kidney or thrombotic microangiopathy . Renal biopsy definitely still plays the most vital and irreplaceable role in the investigations of cases with unexplained renal impairment. Despite a vastly variable biopsy results between patients, renal biopsy has helped in determining the best treatment and prognosis for the patients.

Conditions

Renal Impairment

Keywords

renal biopsy, CKDu Egypt, unexplained elevated serum creatinine

Outcome Measures

Primary Outcomes (1)

• correlation between histopathological findings and serum creatinine in umol/l

  histopathological patterns in term of glomerlular pathology, interstitial fibrosis, tubular injury and serum creatinine in umol /l

  3 years

Interventions

renal biopsy PROCEDURE

Renal biopsy samples will be obtained by a percutaneous method using a spring-loaded Trucut® biopsy needle under real time ultrasound guidance. Biopsy samples will be processed for light microscopy with special staining will be done: Schiff periodic acid, Masson trichrome and methenamine silver.and immunofluorescence studies to evaluate IgA, IgG, IgM, complement C1q and C3, fibrin, and kappa and lambda light chain deposits.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients attended to outpatient clinics or admitted to internal medicine department in assiut univesity hospital

You may qualify if:

• Impaired renal function (serum creatinine\> 115umol/l serum urea \> 8 mmol/l)
• Negative immunological markers i.e ANA, ANCA, cryoglobulin, and complement level.

You may not qualify if:

• Diabetic patients.
• Hypertensive patients.
• All causes of Acute kidney injury
• Bleeding diathesis.
• Known cases of primary or secondary glomerulonephritis.
• Patients with a single functioning kidney
• small sized kidneys
• Multiple renal cysts and ADPKD.
• Patients with asymmetrical kidney size.
• Patient with active infections.
• HBsAg, HCV and HIV positive patients.
• Obstructive uropathy.
• Patients with active malignancies e.g multiple myeloma
• Renal transplant.
• Refusal to do a biopsy

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (1)

• Ellisy RA, Tony EA, Ismail W, Radi R, Seddik MI, Abdel Aziz EM. Clinicopathological characteristics and outcomes of patients with unexplained renal impairment: A single center study. Nefrologia (Engl Ed). 2025 Mar;45(3):249-258. doi: 10.1016/j.nefroe.2025.02.012.

  PMID: 40082054 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Renal biopsy spicemin retained in diluted formaldyde

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 13, 2018
• Study Start: June 13, 2018
• Primary Completion: May 31, 2021
• Study Completion: May 1, 2022
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

EG (1)