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Renal Biopsy Unexplained Elevated Serum Creatinine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03586531
Recruitment Status : Active, not recruiting
First Posted : July 13, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Radwa Ellisy, Assiut University

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.


Condition or disease Intervention/treatment
Renal Impairment Procedure: renal biopsy

Detailed Description:

Chronic kidney disease (CKD) can be considered to be present if a patient has a glomerular filtration rate (GFR) <60 mL/min or markers of structural kidney disease that have been present for >3 months. These include proteinuria, haematuria and radiological abnormalities.

CKD is an important global-health challenge. It is found in 10% of the global population. The age-standardized global prevalence of CKD stages 1-5 in adults aged 20 and older was 10.4% in men and 11.8% in women. The incidence of end-stage renal failure is increasing worldwide with an annual growth rate of 8%.

In 2010, the total number of renal replacement therapy (RRT) patients worldwide amounted to 2.6 million, whereas the number of patients needing this treatment was estimated to be between 4.9 and 9.7 million, with the largest gap between need and supply of RRT in low-income countries, particularly in Asia and Africa.

In 2013, Egypt was among the countries for which CKD was ranked in the top 10 for years of life lost (YLL, calculated by multiplying numbers of deaths by life expectancy at time of death in a reference population) due to premature death and disability-adjusted life years (DALYs) to reflect the degree of disability such as pain or functional limitations caused by each condition.

Early detection and treatment of CKD can be implemented at minimal cost and will reduce the burden of ESRD, improve outcomes of diabetes and cardiovascular disease (including hypertension), and substantially reduce morbidity and mortality from non communicable diseases (NCDs).

Diabetes and hypertension are the predominant risk factors for chronic kidney disease (CKD) globally. Infectious diseases resulting in glomerulonephritis are also important in low-income countries. However, in the past two decades, a severe form of CKD has been reported in individuals without these risk factors. CKD of unknown etiology (CKDu) affects adults in their third to fifth decade and is often fatal due to disease progression and lack of dialysis or transplant options in the involved geographic areas. CKDu has been reported in Sri Lanka, several Central American countries, the state of Andhra Prakesh in India and Egypt.

Besides the conventional work up of CKD cases, renal biopsy is indicated in patients with CKD whose kidneys are normal or near normal in size, where the diagnosis cannot be made by other means.

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Renal Biopsy Findings In Patients With Unexplained Elevated Serum Creatinine In Assiut University Hospital
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Creatinine


Intervention Details:
  • Procedure: renal biopsy
    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.


Primary Outcome Measures :
  1. correlation between histopathological findings and serum creatinine in umol/l [ Time Frame: 3 years ]
    histopathological patterns in term of glomerlular pathology, interstitial fibrosis, tubular injury and serum creatinine in umol /l


Biospecimen Retention:   Samples Without DNA
Renal biopsy spicemin retained in diluted formaldyde


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients attended to outpatient clinics or admitted to internal medicine department in assiut univesity hospital
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586531


Locations
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Egypt
Assiut University Hospital
Assiut, Egypt, 71515
Sponsors and Collaborators
Assiut University
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Responsible Party: Radwa Ellisy, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03586531    
Other Study ID Numbers: RBUESCAUH
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Radwa Ellisy, Assiut University:
renal biopsy
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases