Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:46 PM
Ignite Modification Date:
2025-12-24 @ 6:46 PM
NCT ID:
NCT01779557
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18, male or female
* Patients with end stage renal diseases
* Dialysis mode: CAPD
* Dialysis duration:≥30 days and ≤6 months
* Be capable of implementing home dialysis
* Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min
* Sign the written informed consent
Exclusion Criteria:
* Acute renal failure
* Planing to receive kidney transplantation in 2 years
* Hemodialysis
* Exit site infection or tunnel infection
* Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC\>100×106/L, neutrophil ratio\>50%; c.culture positive/ Gram stain positive in drainage fluid;
* Anti-HIV positive
* Allergic to components of dialysate
* Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb\<80g/L）,malnutrition（Serum Alb\<28g/L）,refractory hypertension
* Identified peritoneal high transportation by peritoneal equilibration test (PET)
* Extreme body shape (height\> 185cm or height \<145cm), obesity (BMI ≥ 33kg/m2)
* Poor compliance
* Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial
* Has a history of alcoholism and drug abuse (defined as illegal drugs)
* Any circumstances when patients are believed unsuitable for this trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01779557
Study Brief:
Protocol Section:
NCT01779557