Condition category
Urological and Genital Diseases
Date applied
28/12/2009
Date assigned
17/02/2010
Last edited
17/02/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mårten Segelmark

ORCID ID

Contact details

Njurkliniken
Universitetssjukhuset i Lund
Lund
221 85
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1476

Study information

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

Acronym

Honeydew III

Study hypothesis

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

The Regional Ethical Review Board in Lund pending approval as of 11/01/2010.

Study design

Open randomised prospective controlled parallel-group multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Gluconic and citric acid (Honeydew), acetic acid (SelectBagOne®), citric acid (Honeycit)

Primary outcome measures

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 trial start date

15/04/2010

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90 randomised patients

Participant 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

Recruitment start date

15/04/2010

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Sweden

Trial participating centre

Njurkliniken
Lund
221 85
Sweden

Sponsor information

Organisation

Gambro Lundia AB (Sweden)

Sponsor details

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

Sponsor type

Industry

Website

http://www.gambro.com/se/

Funders

Funder type

Industry

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes