Condition category
Urological and Genital Diseases
Date applied
28/10/2010
Date assigned
09/08/2011
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively 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

Mrs Kristina Hansson

ORCID ID

Contact details

Magistratsvägen 16
Lund
SE-22010
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1485

Study information

Scientific title

Biocompatibility of a new acetic free dialysis fluid (Honeycit) compared to conventional dialysis fluid (Selectbag® One) in an open, randomised, prospective, controlled crossover study

Acronym

Study hypothesis

A new dialysis fluid containing citric acid has been developed. The safety and biocompatibility of citrate containing dialysate has earlier been investigated with positive results. The aim of this study is to verify the biocompatibility during 6 weeks use of the study product.

Ethics approval

Ethics approval pending as of 28/10/2010

Study design

Prospective open label randomised active controlled crossover 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 contact details below to request a patient information sheet

Condition

Chronic renal failure

Intervention

Patients will be randomised to receive dialysis with either
1. New acetic free dialysis fluid (Honeycit)
2. Conventional dialysis fluid (Selectbag® One)

Patients in each group will receive 6 weeks of treatment, followed by a 2 week wash out period, then crossover to the alternative treatment for a further 6 weeks.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Plasma concentration (P) of Advanced Glycation End products (AGEs), analysed by fluorescence (em 430/ex 350), pre- and post- each 6 week treatment phase

Secondary outcome measures

1. Safety:
1.1. Adverse effects (AE) / Severe adverse effects (SAE)
1.2. Plasma (P)-Parathyroid hormone (PTH)
1.3. P-Ionized-calcium
1.4. P-Citrate
1.5. Blood gas (pH, PO2, PCO2, Base excess)
1.6. Blood (B)-Complete Blood Count (Haemoglobin [Hb], Haematocrit [Hct], White Blood Count [WBC], Red Blood Count [RBC] and Platelets)
1.7. P-Electrolytes (sodium [Na], potassium [K], total calcium [tot-Ca], chlorine [Cl], urea and albumin)
1.8. Blood pressure and heart rate
2. Inflammation:
2.1. P- C-reactive Protein (CRP)
2.2. B- Interleukin (IL)-6
2.3. B- IL-1β
2.4. B- Tumour Necrosis Factor (TNF)-α
3. Coagulation:
3.1. B- Thrombin-Antithrombin (TAT)
3.2. B- Activated Partial Thromboplastin Time (APTT)
3.3. Visual rinse-back information and assessment
4. Additional exploratory parameters:
4.1. Biocompatibility:
4.1.1. Carboxymethyllysine (CML)
4.1.2. Pentosidine
4.1.3. Pentraxin-related protein (PTX3)
4.1.4. Glutathione (GSH/GSSG)
4.1.5. Malondialdehyde (MDA)
4.1.6. 8-Oxo-2'-deoxyguanosine (8-oxo-dG)
4.1.7. modified Advanced Oxidation Protein Product (mAOPP) (stress biomarker)
4.1.8 Total Aminothiols
4.2. Treatment parameters:
4.2.1. Treatment mode (HD/HDF)
4.2.2. Dialyser
4.2.3. Blood circuit and machine
4.2.4. Body weight before and after treatment
4.2.5. Treatment time
4.2.6. Blood flow rate
4.2.7. Dialysis flow rate
4.2.8. Ultra filtration rate and volume
4.2.9. Trans-Membrane Pressure (TMP)
4.2.10. Arterial and venous pressure
4.2.11. Accumulated blood volume and where applicable total infusion volume
4.2.12. Anticoagulation (type, dosage and administration) and potassium level. Diascan Kt/V

All outcomes will be assessed pre- and post- each 6 week treatment phase.

Overall trial start date

17/01/2011

Overall trial end date

27/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Chronic renal failure
2. Stable patients treated on Gambro Select® system (AK200S or AK200 Ultra S) 3 times/week for at least 4 weeks using SelectBag® One (Ca+1.5 mmol/l)
3. Patients treated in haemodialysis (HD) or Haemodiafiltration (HDF) mode with a blood flow rate between 250-400 ml/min during 4-5.5 hours
4. Patients treated with Gambro high flux filter; Polyflux 170H or Polyflux 210H
5. Signed consent to participate in the study (informed consent)
6. Patient aged 18 years or older, male or female
7. Haemoglobin 10 to 13.5 g/dl (haematocrit 30% to 40%)
8. Patients able to tolerate prescribed dialysis fluid with electrolyte concentrations as specified for the test device
9. Technical survival during study period as judged by study investigator

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant exclusion criteria

1. Known Human Immunodeficiency Virus (HIV), Hepatitis C or B Virus (HCV or HBV) infection (positive serology)
2. Patients with ionized-calcium value < 1.1 mmol/l
3. Patients unable to tolerate Citrate as judged by Investigator
4. Patients using Citrate anticoagulation in usual HD treatment
5. Pregnant / planning pregnancy and lactating women during study period
6. Patients with acute inflammatory or infectious event which, as judge by Investigator, may affect the safety of the patient and/or the result of the study
7. Patients with known haemodynamic instability that, as judged by the investigator, might cause clinical treatment problems
8. Chronic single needle dialysis
9. Participation in other studies during the study period that can affect the outcome of this study
10. Patients not considered compliant in following the study protocol, as judged by Investigator

Recruitment start date

17/01/2011

Recruitment end date

27/05/2011

Locations

Countries of recruitment

Sweden

Trial participating centre

Magistratsvägen 16
Lund
SE-22010
Sweden

Sponsor information

Organisation

Gambro Lundia AB (Sweden)

Sponsor details

Magistratsvägen 16
P.O.Box 10101
Lund
SE-22010
Sweden
kristina.hansson@gambro.com

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Gambro (Sweden)

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24103587

Publication citations

  1. Results

    Grundström G, Christensson A, Alquist M, Nilsson LG, Segelmark M, Replacement of acetate with citrate in dialysis fluid: a randomized clinical trial of short term safety and fluid biocompatibility., BMC Nephrol, 2013, 14, 216, doi: 10.1186/1471-2369-14-216.

Additional files

Editorial Notes