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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05819320
Other study ID # skin manifestations in CKD
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date April 2025

Study information

Verified date April 2024
Source Assiut University
Contact Marwa Hassan Mohammed, M,B,B,CH
Phone 01224456778
Email marwahassan99956@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

1. To study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital . 2. Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Eldakhla general hospital in New Vally and pediatric and adult renal units of Assuit university hospital .


Description:

Chronic kidney disease (CKD) is defined as abnormalities of kidney structure or function , present for > 3 months , with implications for health . chronic kidney disease is classified based on cause , Glomerular Filtration Rate category (G1-G5) , and Albuminuria category ( A1-A3) , abbreviated as CGA . (Michel et al.,2023). Chronic kidney disease (CKD) affects up to 13% of the population and may progress to kidney failure and death. Some risk factors for chronic kidney disease are well known such as high blood pressure and diabetes. There is some evidence that inflammatory skin diseases such as eczema and psoriasis may also increase the risk of chronic kidney disease . (Schonmann et al.,2021). Skin serves as the mirror of underlying systemic problems. The early diagnosis of subtle cutaneous clinical pointers often helps in identifying renal disorders, obviating the delay in diagnosis and treatment. Cutaneous changes can be observed from the beginning of renal impairment until the evolution to terminal stage . ( Vivek et al,2021) Most patients with severe chronic kidney disease progress to end stage renal disease (ESRD). Cutaneous manifestations are common in all stages of chronic kidney disease particularly towards end stage renal disease . (Rattan et al.,2018). The prevalence of chronic kidney disease is increasing, and the incidence and prevalence of associated skin diseases will also increase. Their early recognition and treatment to reduce morbidity and mortality are essential . (Timur et al,2014) Many factors are involved in the pathogenesis of the cutaneous manifestations of end stage renal disease , including electrolyte imbalance, buildup of uremic substances, and comorbid disease (Goldman et al,2012). There are two main categories of the cutaneous manifestations of chronic kidney diseases: nonspecific and specific. Nonspecific manifestations include pruritus, skin color changes, xerosis, and half-and-half nails. Specific manifestations include acquired perforating dermatosis, bullous dermatoses, metastatic calcification, and nephrogenic systemic fibrosis. (Goldman et al,2012). The pattern of mucocutaneous manifestations of chronic kidney disease in Eldakhla, the New Valley, Egypt, are not studied before.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date April 2025
Est. primary completion date March 2025
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients with chronic kidney disease attending the renal unit of internal medicine of Eldakhla General hospital, New Vally ,and Assiut University hospital will be included in this study within two years and will be examined for any skin manifestations and mucocutaneous findings. Exclusion Criteria: - Human immunodeficiency (HIV) affected persons, renal transplant recipients, and patients with acute renal failure, hepatobiliary, pancreatic, or thyroid disorders, cutaneous or systemic malignancies will be excluded.

Study Design


Intervention

Other:
observe pattern of mucocutaneous manifestations in chronic kidney disease patients
To study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients . Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Galperin TA, Cronin AJ, Leslie KS. Cutaneous manifestations of ESRD. Clin J Am Soc Nephrol. 2014 Jan;9(1):201-18. doi: 10.2215/CJN.05900513. Epub 2013 Oct 10. — View Citation

Goel V, Sil A, Das A. Cutaneous Manifestations of Chronic Kidney Disease, Dialysis and Post-Renal Transplant: A Review. Indian J Dermatol. 2021 Jan-Feb;66(1):3-11. doi: 10.4103/ijd.IJD_502_20. — View Citation

Rashpa RS, Mahajan VK, Kumar P, Mehta KS, Chauhan PS, Rawat R, Sharma V. Mucocutaneous Manifestations in Patients with Chronic Kidney Disease: A Cross-sectional Study. Indian Dermatol Online J. 2018 Jan-Feb;9(1):20-26. doi: 10.4103/idoj.IDOJ_160_17. — View Citation

Schonmann Y, Mansfield KE, Mulick A, Roberts A, Smeeth L, Langan SM, Nitsch D. Inflammatory skin diseases and the risk of chronic kidney disease: population-based case-control and cohort analyses. Br J Dermatol. 2021 Oct;185(4):772-780. doi: 10.1111/bjd.20067. Epub 2021 Jun 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Eldakhla general hospital in New Vally and pediatric and adult renal units of Assuit university hospital . Base line
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