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

ISRCTN	ISRCTN60694941
DOI	https://doi.org/10.1186/ISRCTN60694941
Secondary identifying numbers	1476

Submission date: 28/12/2009
Registration date: 17/02/2010
Last edited: 17/02/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Mårten Segelmark
Scientific

Njurkliniken
Universitetssjukhuset i Lund
Lund
221 85
Sweden

Study information

Study design	Open randomised prospective controlled parallel-group multicentre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Biocompatibility of a new haemodialysis concentrate containing gluconic and citric acid (Honeydew) compared to acetic acid (SelectBagOne®) and citric acid (Honeycit) in an open, randomised, prospective, controlled and parallel-group study
Study acronym	Honeydew III
Study objectives	To collect biocompatibility data on a new haemodialysis fluid (containing gluconic acid and citric acid) for scientific communication. The primary objective is to investigate the biocompatibility of the new HD concentrate containing gluconic and citric acid during 8 weeks of HD treatment by comparing it with the HD concentrate with acetic acid.
Ethics approval(s)	The Regional Ethical Review Board in Lund pending approval as of 11/01/2010.
Health condition(s) or problem(s) studied	Chronic renal failure
Intervention	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 citric acid (Honeydew), or 2. Citric acid (Honeycit), or 3. Acetate (SelectBagOne®) No follow-up period.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Gluconic and citric acid (Honeydew), acetic acid (SelectBagOne®), citric acid (Honeycit)
Primary outcome measure	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 outcome measures	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
Overall study start date	15/04/2010
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	90 randomised patients
Key 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
Key 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
Date of first enrolment	15/04/2010
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

Sweden

Study participating centre

Njurkliniken

Lund
221 85
Sweden

Sponsor information

Gambro Lundia AB (Sweden)
Industry

Magistratsvägen 16
P.O. Box 10101
Lund
220 10
Sweden

Website	http://www.gambro.com/se/
"ROR"	https://ror.org/05mw5ed57

Funders

Funder type

Industry

Gambro Lundia AB (Sweden) (ref: 556057-7594)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan