NCT03532568

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

April 26, 2018

Last Update Submit

May 10, 2018

Conditions

Chronic Kidney Disease-associated Pruritus

Outcome Measures

Primary Outcomes (2)

  • 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.

    6 months

  • Estimation of tissue levels of Klotho and FGF23 BY ELISA after treatment with narrowband ultraviolet B in chronic kidney disease-associated patients.

    6 months

Study Arms (3)

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

Other: skin biopsyRadiation: narrowband ultraviolet B

CKD patients without pruritis

EXPERIMENTAL

skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue

Other: skin biopsy

normal healthy participants

EXPERIMENTAL

skin biopsy for Klotho and fibroblast growth factor 23 levels in skin tissue

Other: skin biopsy

Interventions

skin biopsyOTHER

4mm punch skin biopsy

CKD patients without pruritisCKD-aP patientsnormal healthy participants
narrowband ultraviolet BRADIATION

narrowband ultraviolet B for CKD-aP patients

CKD-aP patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with CKD on dialysis.
  • Age \>18 years old.
  • Both sexes.

You may not qualify if:

  • Age \<18 years old.
  • Any contraindication to phototherapy (e.g, past skin cancer) for those with pruritus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 22, 2018

Study Start

May 1, 2018

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05