Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03586531 |
Other study ID # |
RBUESCAUH |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 13, 2018 |
Est. completion date |
May 1, 2022 |
Study information
Verified date |
July 2023 |
Source |
Assiut University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.