Chronic Kidney Disease-associated PruritusNCT03532568
Klotho in Chronic Kidney Disease-associated Pruritis (CKD-aP)
A study testing skin biopsy and narrowband ultraviolet B in people with Chronic Kidney Disease-associated Pruritus, run by Cairo University.
Trial summary
Studying whether Klotho and FGF23 have a role in UP and whether their expression change by BB-UVB with the improvement of pruritus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease-associated Pruritus
- What is being tested?
- skin biopsy and narrowband ultraviolet B
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Dec 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with CKD on dialysis.
- Age >18 years old.
- Both sexes.
Who cannot join
- Age <18 years old.
- Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.
About this study
Official title: Klotho and Fibroblast Growth Factor 23 in Chronic Kidney Disease-associated Pruritus and Their Response to Narrowband Ultraviolet B
Studying whether Klotho and FGF23 have a role in UP and whether their expression change by BB-UVB with the improvement of pruritus.
Read the 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.
- Being tested
- skin biopsy, narrowband ultraviolet B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin biopsyOther
4mm punch skin biopsy
narrowband ultraviolet BRadiation
narrowband ultraviolet B for CKD-aP patients
| Study group | Role | What they receive |
|---|---|---|
| CKD-aP patients | Experimental | skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue and their response to narrow band ultraviolet B Receives: Other: skin biopsy; Radiation: narrowband ultraviolet B |
| CKD patients without pruritis | Experimental | skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue Receives: Other: skin biopsy |
| normal healthy participants | Experimental | skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue Receives: Other: skin biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Estimation of tissue levels of Klotho and FGF23 BY ELISA after treatment with narrowband ultraviolet B in chronic kidney disease-associated patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startMay 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease-associated PruritusStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Fathy Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532568
- Sponsor's protocol ID
- Dermatology 8
- Status last verified
- May 2018
- First submitted
- 26 Apr 2018
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Klotho and Fibroblast Growth Factor 23 in Chronic Kidney Disease-associated Pruritus and Their Response to Narrowband Ultraviolet B
- ClinicalTrials.gov ID
- NCT03532568
- Acronym / sponsor ID
- Dermatology 8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 May 2018 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CKD-aP patients | Experimental | Other: skin biopsy, Radiation: narrowband ultraviolet Bskin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue and their response to narrow band ultraviolet B |
| CKD patients without pruritis | Experimental | Other: skin biopsyskin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue |
| normal healthy participants | Experimental | Other: skin biopsyskin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with CKD on dialysis.
- Age >18 years old.
- Both sexes.
Key exclusion criteria (2 listed)
- Age <18 years old.
- Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.
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 |
|---|---|---|
| skin biopsy4mm punch skin biopsy | Other | CKD patients without pruritis, CKD-aP patients, normal healthy participants |
| narrowband ultraviolet Bnarrowband ultraviolet B for CKD-aP patients | Radiation | CKD-aP patients |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing skin biopsy and narrowband ultraviolet B in people with Chronic Kidney Disease-associated Pruritus, run by Cairo 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 3 inclusion and 2 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 22 May 2018. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2018.