Chronic Kidney DiseasesNCT05819320
Mucocutaneous Manifestations in Patients With Chronic Kidney Disease inNewVally and Assuit;Hospital Based Study
An observational study of Chronic Kidney Diseases and Manifestation, Skin, run by Assiut University.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Diseases, Manifestation, Skin
- What is being tested?
- observe pattern of mucocutaneous manifestations in chronic kidney disease patients
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Apr 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 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 . Detailed medical history, clinical examination and investigations which support the diagnosis will be recorded including: urine analysis, CBC, Blood urea, creatinine , x- ray, arterial blood gases , abdominal sonography ,serum electrolytes, multislice CT KUB , Demsa scan ......etc . Potassium hydroxide (KOH) mounts, skin biopsy, Gram's, and Giemsa staining, and bacterial or fungal cultures will be performed when we need.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Mucocutaneous Manifestations in Patients With Chronic Kidney Disease in New Vally and Assuit (Hospital Based Study) .
- To 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 .
Read the detailed 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.
- Conditions
- Chronic Kidney Diseases, Manifestation, Skin
- Being tested
- observe pattern of mucocutaneous manifestations in chronic kidney disease patients
- Medical subject headings
- Renal Insufficiency, Chronic, Skin Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observe pattern of mucocutaneous manifestations in chronic kidney disease patientsOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| ALdakhla general hospital patients | 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 Receives: Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients | |
| Assuit University hospital adult renal unit | patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (adult renal unit ) . Receives: Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients | |
| Assuit University hospital pediatric renal unit | patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (pediatric renal unit ). Receives: Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study startJun 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Hassan Mohammed Ahmed, Assiut University
- Investigators
- Doaa Samir sayed, Study director, SupervisorEman Mohammed kamal Elsayed Yousef, Study director, SupervisorMarwa Hassan Mohammed, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819320
- Sponsor's protocol ID
- skin manifestations in CKD
- Status last verified
- Apr 2024
- First submitted
- 6 Apr 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33730366Rashpa 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.
PubMed 29441293Galperin 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.
PubMed 24115194Goel 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.
PubMed 33911288
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Mucocutaneous Manifestations in Patients With Chronic Kidney Disease in New Vally and Assuit (Hospital Based Study) .
- ClinicalTrials.gov ID
- NCT05819320
- Acronym / sponsor ID
- skin manifestations in CKD
- Conditions
- Chronic Kidney Diseases, Manifestation, Skin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To 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 .
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALdakhla general hospital patients | – | Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patientspatterns 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 |
| Assuit University hospital adult renal unit | – | Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patientspatterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (adult renal unit ) . |
| Assuit University hospital pediatric renal unit | – | Other: observe pattern of mucocutaneous manifestations in chronic kidney disease patientspatterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease in renal unit of internal medicine of Assuit University hospital (pediatric renal unit ). |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 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 . Detailed medical history, clinical examination and investigations which support the diagnosis will be recorded including: urine analysis, CBC, Blood urea, creatinine , x- ray, arterial blood gases , abdominal sonography ,serum electrolytes, multislice CT KUB , Demsa scan ......etc . Potassium hydroxide (KOH) mounts, skin biopsy, Gram's, and Giemsa staining, and bacterial or fungal cultures will be performed when we need.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observe pattern of mucocutaneous manifestations in chronic kidney disease patients1. To study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients . 2. Comparison of the patterns of mucocutaneous manifestations and their correlation with the different stages of Chronic Kidney Disease | Other | ALdakhla general hospital patients, Assuit University hospital adult renal unit, Assuit University hospital pediatric renal unit |
Primary outcome
study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital
Time frame: Base line
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 33730366Schonmann 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.
- Background: PubMed 29441293Rashpa 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.
- Background: PubMed 24115194Galperin 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.
- Background: PubMed 33911288Goel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doaa Samir sayed study director
Supervisor
Eman Mohammed kamal Elsayed Yousef study director
Supervisor
Marwa Hassan Mohammed principal investigator
Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Manifestation, Skin, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Hassan Mohammed, M,B,B,CH (01224456778, marwahassan99956@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
study the patterns of mucocutaneous disorders in Chronic Kidney Disease patients in Eldakhla General Hospital, New Valley and in Assiut University hospital (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819320, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.