Biocompatibility of a new haemodialysis concentrate containing gluconic and citric acid (Honeydew) compared to acetic acid (SelectBagOne®) and citric acid (Honeycit)

Completed

• Conditions: Chronic renal failure; Urological and Genital Diseases

• Registration Number: ISRCTN60694941
• Lead Sponsor: Gambro Lundia AB (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Chronic renal failure
2. Stable patients treated 3 times/week for at least 1 month
3. Patients treated in HD mode with a blood flow rate between 250 - 400 ml/min during 4 - 5.5 hours
4. Patients treated with Gambro high flux filter (e.g. Polyflux 170H or Polyflux 210H)
5. Patients treated with Gambro AK200S or AK200 Ultra S with select system
6. Written consent to participate in the study (informed consent)
7. Patient aged 18 years or older, either sex
8. Vascular access able to deliver blood flow rate of greater than or equal to 250 ml/min
9. Haemoglobin 10 - 13.5 g/dl (haematocrit 30% to 40%)
10. Patients able to tolerate prescribed dialysis fluid with electrolyte concentrations as specified for the test device
11. Technical survival during study period as judged by study investigator

Exclusion Criteria

1. Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) infection (positive serology)
2. Patients unable to tolerate citrate
3. Patients using citrate anticoagulation in usual HD treatment
4. Pregnant and lactating women
5. Patients with acute inflammatory or infectious event that, as judged by the investigator, may affect the safety of the patient and/or the results of the study
6. Patients with known haemodynamic instability that could cause, as judged by the investigator, clinical treatment problems
7. Chronic single needle dialysis
8. Participation in other studies during the study period that will affect the outcome of this study
9. Patients not considered compliant to follow the study protocol, as judged by investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentration of Advanced Glycation End products (AGE). Analysing method: Fluorescence (em 430/ex 350).<br><br>Sampling for all endpoints will be done at T0, T1 and T2:<br>T0: (baseline) sampling when entering into the randomised treatment-period<br>T1: sampling after 4 weeks in treatment-period<br>T2: sampling after 8 weeks in treatment-period