Klotho in Chronic Kidney Disease-associated Pruritis (CKD-aP)
Primary Purpose
Chronic Kidney Disease-associated Pruritus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
skin biopsy
narrowband ultraviolet B
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Kidney Disease-associated Pruritus
Eligibility Criteria
Inclusion Criteria:
- Patients with CKD on dialysis.
- Age >18 years old.
- Both sexes.
Exclusion Criteria:
- Age <18 years old.
- Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
CKD-aP patients
CKD patients without pruritis
normal healthy participants
Arm Description
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue and their response to narrow band ultraviolet B
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue
Outcomes
Primary Outcome Measures
Estimation of tissue levels of Klotho and FGF23 by ELISA in chronic kidney disease-associated pruritis and chronic kidney disease patients and comparing them with healthy control subjects.
Estimation of tissue levels of Klotho and FGF23 BY ELISA after treatment with narrowband ultraviolet B in chronic kidney disease-associated patients.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03532568
Brief Title
Klotho in Chronic Kidney Disease-associated Pruritis (CKD-aP)
Official Title
Klotho and Fibroblast Growth Factor 23 in Chronic Kidney Disease-associated Pruritus and Their Response to Narrowband Ultraviolet B
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Studying whether Klotho and FGF23 have a role in UP and whether their expression change by BB-UVB with the improvement of pruritus.
Detailed Description
Uremic pruritus (UP), also known as Chronic Kidney Disease-associated pruritus (CKD-aP), is the most common cause of Generalized Pruritus (GP). UP is multifactorial; not due to a single cause but as a result of combined action of multiple factors. UP has a major clinical impact because it is strongly associated with poor quality of life, impaired sleep, depression, and increased mortality. UP patient always feels he is drained and distressed.
Alpha Klotho is the protein product of the anti-aging klotho gene. This protein exists in two forms: soluble Klotho (s-Klotho) and membranous Klotho (m-Klotho). The kidney is the principal organ that produces, regulates, and metabolizes Klotho.
Membranous Klotho acts as a co-receptor to enhance the binding of fibroblast growth factor 23 (FGF23) to FGF receptors (FGFRs) through the formation of Klotho/FGFR/FGF23 complex. Interestingly, soluble Klotho can also bind to FGF23/FGFR, but it prevents high FGF23-induced toxicity.
In chronic kidney disease( CKD), soluble Klotho is still detectable although it is much lower than in healthy human beings, suggesting that it is produced from extrarenal organ(s) or tissue(s) not yet identified which may be the skin.
FGF23 is a peptide released from bone tissue osteocytes and osteoblasts. It plays an important role in the bone-kidney axis and the regulation of calcium and phosphate homeostasis. In CKD, Klotho is linearly decreased prior to the rise of FGF23 so it is considered a biomarker for early detection of kidney damage.
Klotho deficiency contributes to vascular and soft-tissue calcification in CKD patients. In CKD-aP patients, there is metastatic micro-calcification due to calcium deposition in skin and this is one of the etiological causes of UP. Whether Klotho has a role in this assumption is still unclear.
Phototherapy is a proven method for the management of many pruritic disorders. Narrowband ultraviolet B (NB-UVB) can be considered as a feasible treatment option for CKD-aP. One of its possible mechanisms is the reduction of skin calcium-ion content. Whether this is via changing Klotho expression is still unknown.
Therefore, our study aims at knowing whether Klotho and FGF23 have a role in UP and whether their expression change by NB-UVB with the improvement of pruritus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease-associated Pruritus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CKD-aP patients
Arm Type
Experimental
Arm Description
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue and their response to narrow band ultraviolet B
Arm Title
CKD patients without pruritis
Arm Type
Experimental
Arm Description
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue
Arm Title
normal healthy participants
Arm Type
Experimental
Arm Description
skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue
Intervention Type
Other
Intervention Name(s)
skin biopsy
Intervention Description
4mm punch skin biopsy
Intervention Type
Radiation
Intervention Name(s)
narrowband ultraviolet B
Intervention Description
narrowband ultraviolet B for CKD-aP patients
Primary Outcome Measure Information:
Title
Estimation of tissue levels of Klotho and FGF23 by ELISA in chronic kidney disease-associated pruritis and chronic kidney disease patients and comparing them with healthy control subjects.
Time Frame
6 months
Title
Estimation of tissue levels of Klotho and FGF23 BY ELISA after treatment with narrowband ultraviolet B in chronic kidney disease-associated patients.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with CKD on dialysis.
Age >18 years old.
Both sexes.
Exclusion Criteria:
Age <18 years old.
Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.
12. IPD Sharing Statement
Learn more about this trial
Klotho in Chronic Kidney Disease-associated Pruritis (CKD-aP)
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