End-stage Kidney disease. End stage renal disease
Conditions
Interventions
Intervention 1: Intervention group: Oral Tacrolimus capsule. Intervention 2: Control group: placebo.
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Age range between 18 and 60 years Patients with dialysis adequacy 3 times a week Dialysis patients with chronic itching for more than 3 months Average VAS score greater than 4 for 5 days prior to the start of the intervention Patients who agree to participate in this trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: Intact parathyroid hormone greater than 1000 pg/mL within 1 month Serum potassium greater than 6 mg/dL Viral diseases (HBV, HIV, etc.) Aspartate transaminase (glutamic oxaloacetic transaminase) or alanine transaminase (glutamic pyruvic transaminase) more than 3 times the upper limit of normal History of active cancer undergoing treatment Patients scheduled for kidney transplantation within the next 3 months Active infection under treatment Current itching associated with skin conditions other than uremic itching Pregnancy or plan for pragnancy during the study period, or breastfeeding Allergic or hypersensitivity reaction to tacrolimus History of participating in another clinical trial within 2 months or planning to participate in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uremic pruritus improvement rate; plasma interleukin 13 levels; interleukin 13 receptor gene expression. Timepoint: First, end of fourth week, end of eighth week. Method of measurement: VAS scale; ELISA, and Real time PCR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete blood cell count, serum glucose, uric acid, total protein, albumin, total bilirubin, aspartate transaminase, alanine transaminase, alkaline phosphatase, blood urea, creatinine, and total cholesterol. Timepoint: First, end of fourth week, end of eighth week. Method of measurement: Autoanalyzer device. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Masjedi
Shiraz University of Medical Sciences
Outcome results
None listed