A Study of Domestic Automated Peritoneal Dialysis Machine

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of domestic APD machine compared with the patients followed CAPD.

Detailed Description
-----------------
Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and almost of them followed continuous ambulatory peritoneal dialysis (CAPD) because of the expensive price of import automated PD (APD) machines although the higher clearance of solute, lower rate of PD related peritonitis and higher quality of life (QOL) in patients treated with APD compared those with CAPD. Now, cheaper domestic APD machines ( PDGO, Fuzhou, China) are accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive APD while those in control group will receive CAPD for 8 weeks. After followed-up for 8 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.

Official Title
-----------------
Validity and Security of Domestic Automated Peritoneal Dialysis Machine: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial

Conditions
-----------------
Disorders Associated With Peritoneal Dialysis

Intervention / Treatment
-----------------
* Other: APD
* Other: CAPD


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: The duration of PD is more than 1 month. The age is range from 18 to 80 years old. The patient can be treated with regular PD in home. The volume of peritoneal dialysate is from 8L to 10 L in 1 day. The patient can be visited regularly. The patient must be freely given informed consent Exclusion criteria: Peritonitis was happened within 1 month The KT/V<1.7 Infections in the exit or tunnel With tumors. With low transport of peritoneum. With mental and behavior disorders. With acute renal failure Hemodialysis meanwhile With heart failure( NYHA III-IV ) or cardio- cerebrovascular events Attending other clinical trails Refused to give informed consent Exit criteria （1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A APDGroup<br>PDGO APD machines used in the PD patients for 8 weeks | Other: APD<br>* PDGO APD machines used in the PD patients for 8 weeks<br>|
| Active Comparator: B CAPDGroup<br>CAPD used in the PD Patients for 8 weeks | Other: CAPD<br>* CAPD used in the PD Patients for 8 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of dialysis | kt/v | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual kidney function | Residual kidney kt/v | up to 6 months | 
| Peritoneal function | Peritoneal equilibration test | up to 6 months |