Chronic renal failure Urological and Genital Diseases Chronic renal failure
Conditions
Interventions
For all treatment arms:
Starts with a 2-week run-in period for stabilisation (SelectBagOne®), followed by an 8-week treatment period with either of the following hemodialysis fluids:
1. Gluconic and
Sponsors
Gambro Lundia AB (Sweden)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma concentration of Advanced Glycation End products (AGE). Analysing method: Fluorescence (em 430/ex 350). Sampling for all endpoints will be done at T0, T1 and T2: T0: (baseline) sampling when entering into the randomised treatment-period T1: sampling after 4 weeks in treatment-period T2: sampling after 8 weeks in treatment-period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Plasma electrolytes (Na, K, Cl, i-Ca), blood glucose, plasma urea, blood haemostatic parameters (Hb, Hct, Lpk, Epk and Tpk) and blood gases but also blood pressure, heart rate, adverse events (AE)/serious adverse events (SAE), concomitant medication, patient and treatment parameters 2. Plasma and urine gluconate and plasma and urine citrate 3. Carboxymethyl lysine (CML), serum pentosidine 4. Blood glutathione (GSH, including oxidised glutathione [GSSG]), blood 8-iso-PGF2a (lipid peroxidation), serum modified advanced oxidative protein products [AOPP], blood total aminothiol (gamma glucys, GSH, cysgly, cys, hcy) 5. Plasma C-reactive protein (CRP), plasma tumour necrotising factor alpha (TNFa) and serum pentraxine-3 6. Blood activated clotting time (ACT) and blood thrombin-antithrombin III (TAT) Sampling for all endpoints will be done at T0, T1 and T2: T0: (baseline) sampling when entering into the randomised treatment-period T1: sampling after 4 weeks in treatment-period T2: sampling after 8 weeks in treatment-period | — |
Countries
Sweden
Outcome results
None listed