Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00906555
Other study ID # 08dz1900501-a
Secondary ID
Status Completed
Phase Phase 4
First received May 20, 2009
Last updated October 12, 2016
Start date June 2009
Est. completion date June 2012

Study information

Verified date October 2016
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Adequacy of solute clearance makes a profound impact on clinical outcome in maintenance hemodialysis patients. Thus far, guidelines on the target of solute clearance (Kt/V or URR) are based on patients with three dialysis sessions per week. However, quite a few patients have their dialysis sessions twice per week in China. The dialysis target of solute clearance in this population remains to be elucidated. The aim of this study was to explore the optimum target solute clearance (Kt/V or URR) in maintenance hemodialysis patients with two dialysis sessions per week. Two groups of hemodialysis patients with different Kt/V (1.2 ≤ Kt/V < 1.7 versus Kt/V ≥ 1.7) will be followed until 96 weeks in this prospective, randomized, multi-center, interventional study.


Description:

This is a prospective, randomized, multi-center intervention study. 400 maintenance hemodialysis patients with twice dialysis sessions per week will be enrolled into the study. All the patients have their baseline Kt/V between 1.2 and 1.7 (1.2 ≤ Kt/V < 1.7). After treatment intervention, the patients will be randomized to two groups according to their different Kt/V (1.2 ≤ Kt/V < 1.7 vs. Kt/V ≥ 1.7), then the patients will be regularly followed up at baseline, 12 weeks, 24 weeks, 48 weeks, 72 weeks and 96 weeks. Clinical outcomes such as mortality, complications and life quality between the two groups will be investigated.


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Patients undergoing maintenance hemodialysis for more than 12 weeks were included in the study.

2. The patients have their dialysis sessions twice weekly and have baseline Kt/V between 1.2 and 1.7 (1.2 = Kt/V < 1.7).

3. Age from 18 to 80, male or female.

4. Patients have long term vascular access.

Exclusion Criteria:

1. Patients with an expected survival less than 12 months.

2. Without informed consent.

3. Unstable organ disease such as uncurable cancer,active inflammation disease and mental disease.

4. Patients with an expected follow up less than 48 weeks,such as planned kidney transplant.

5. Other conditions regarded as unsuitability by investigator, such as pregnancy, alcohol or drug indulgence. A dry weight more than 90 kg is also excluded in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
modification of hemodialysis parameters on dialysis machine
Modification of hemodialysis parameters such as dialysis time, blood flow rate and dialysate flow rate to reach a Kt/V = 1.7.

Locations

Country Name City State
China Renji Hospital, Shanghai Jiao Tong University school of medicine Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical outcome including mortality and morbidity 2 years Yes
Secondary complications including cardiovascular disease, nutritional and inflammation status, calcium and phosphorus level, anemia and life quality 2 years Yes
See also
  Status Clinical Trial Phase
Recruiting NCT04892745 - Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
Not yet recruiting NCT04925674 - Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis. Phase 1
Active, not recruiting NCT03183245 - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis Phase 3
Completed NCT03365635 - Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C Phase 4
Withdrawn NCT02904343 - Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study N/A
Withdrawn NCT01855334 - L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD Phase 4
Completed NCT01700465 - Estimating and Predicting Hemodynamic Changes During Hemodialysis N/A
Recruiting NCT01195519 - The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis N/A
Completed NCT00737672 - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis Phase 3
Completed NCT00527774 - Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients N/A
Completed NCT00942253 - Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS) Phase 2
Completed NCT00224081 - DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin) Phase 4
Completed NCT00850252 - Use of a Lifeline Graft in the A-V Shunt Model Phase 1/Phase 2
Completed NCT00776750 - Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients Phase 4
Recruiting NCT06351007 - Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK) N/A
Withdrawn NCT03664141 - Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study) Phase 3
Completed NCT03909698 - Antibiotic Dosing in Patients on Intermittent Hemodialysis
Recruiting NCT03311321 - Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients N/A
Recruiting NCT06098924 - HD Patients' Depression and Happiness
Recruiting NCT03419923 - Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage N/A