End-stage renal disease
Conditions
Interventions
Group 1:Gabapentin 100mg, qod
Group 2:Gabapentin 200mg, qod
Group 3:None
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years, right-handed; 2. Meet the clinical diagnostic criteria of stage 5 chronic kidney disease, have received regular peritoneal dialysis treatment for >=3 months, and the number of dialysis times >=4 times per day, and the total urea clearance index (Kt/V) >= 1.7; 3. Be able to tolerate, cooperate with and complete MRI examinations and related neuropsychological tests; 4. No MRI contraindications: including cochlear implants, metal dentures, pacemakers and other metal implants and known claustrophobia; 5. Chronic pruritus for more than six weeks, no history of pruritus before renal failure; 6. The calcium and phosphorus product is normal (<60mg2/dL2), and the serum bile acid is normal (<6µmol/L); 7. Female subjects must be willing to take appropriate contraceptive measures; 8. Voluntary test, signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Known cerebral hemorrhage, non-lacunar cerebral infarction, metabolic encephalopathy (such as hepatic encephalopathy, uremic encephalopathy, hypoxic encephalopathy, etc.), traumatic brain injury, epilepsy, encephalitis, hydrocephalus, brain tumor , multiple sclerosis and other central nervous system diseases; 2. Combined with diabetes; after kidney transplantation; combined with severe hepatic insufficiency, malignant tumor, severe infection, acute pancreatitis, etc.; 3. The presence of primary skin diseases (such as drug-induced hypersensitivity or other allergies, contact dermatitis, psoriasis, xerosis and urticaria, etc.); 4. Other diseases causing itching (such as malignant hematological diseases, human immunodeficiency diseases, viral hepatitis, primary biliary cirrhosis and drug-induced cholestasis); 5. Combined with psychiatric disorders (schizophrenia, etc.) that interfere with cognitive testing or follow-up; 6. Use of drugs that may affect cognitive function, including sedatives, anxiolytics, hypnotics, and cholinergic drugs; 7. Those who are known or suspected to be allergic to the components of this product or the reference drug, are addicted to drugs or alcohol, and are participating in clinical trials of other drugs; 8. Parathyroid hormone (PTH)>1000pg/mL, eosinophilia (count>500/mm3) or/and increased serum IgG (>120 UI/mL).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pruritus visual analogue scale;3D T1 structural Image;resting state blood oxygen dependent level;diffusion kurtosis imaging;Pittsburgh sleep qualityindex (PSQI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck anxiety inventory (BAI);Beck depression inventory (BDI); | — |
Countries
China
Contacts
Public ContactLyu Jing
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed