None listed
Conditions
Brief summary
Haemodialysis remains a principal renal replacement modality for patients with end stage renal disease (ESRD). Despite the efficacy of haemodialysis as a treatment to replace essential kidney functions, such as fluid and acid-base balance, the morbidity and mortality of patients receiving haemodialysis remains high when compared with the general population. Of many factors, the inadequate removal of some uraemic solutes might play a role in this phenomenon. Middle molecules are a well described class of uraemic solutes which have been linked to both the reduced quality of life and survival associated with end stage kidney disease. To date larger middle molecules have been inadequately removed by haemodialysis strategies. The mid cut-off dialyser Theranova represents a new class of dialysis membranes with the ability to remove nearly all middle molecules. REMOVAL-HD is a pivotal, open label, non-randomized, single-arm, multi-center device study. The primary objective of the REMOVAL-HD study is to determine if regular haemodialysis using the Baxter Theranova dialyser in a chronic haemodialysis population can significantly decrease serum concentrations of large middle molecules without resulting in a significant loss of albumin. Participant will have 4 weeks wash-in period of high flux haemodialysis, then 26 weeks of treatment the mid cut-off dialyser Theranova and then 4 weeks wash-out with high flux haemodialysis. The primary study outcome is change in serum albumin at 6 months. Secondary outcomes include levels of uremic toxins over 6 months of treatment, the burden of HD related symptoms such as restless legs and general quality of life, functional measures of the 6-minute walk and rate of hospitalizations, infections and death.
Interventions
Participants will receive six months’ treatment with the Theranova dialyzer three times per week. Theranova, the Baxter Mid Cut-Off dialyzer has a pore size of 7 nm but narrower distribution of pores compared to high cut-off membrane. It has been designed to provide increased clearance of these larger middle-molecules in chronic haemodialysis patients, compared with high flux HD (the standard HD treatment method).
Prior to intervention, participants will also receive a one-month wash-in and on
Participants will receive six months’ treatment with the Theranova dialyzer three times per week. Theranova, the Baxter Mid Cut-Off dialyzer has a pore size of 7 nm but narrower distribution of pores compared to high cut-off membrane. It has been designed to provide increased clearance of these larger middle-molecules in chronic haemodialysis patients, compared with high flux HD (the standard HD treatment method). Prior to intervention, participants will also receive a one-month wash-in and one month wash out period after treatment period using the Revaclear high-flux membrane. Although all dialysis prescriptions will remain under the supervision of the local nephrology team (thus prescriptions may vary based on local and individual patient requirements), the following treatment guidance is provided: - target blood flow >300mls/min, - dialysate flow rate 500mls/min, - fluid removal to participant’s individual prescription All participants are in-centre patients and will be withdrawn from treatment if participant transfers to another renal unit which is not an active study site
Sponsors
The University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Established chronic in-centre HD patient (>12 weeks on HD) 2. Has a functioning Arterio Venous Fistula or Graft 3. Either oliguric (<500mls/24hrs based on 24hr urine collection within 12 weeks of screening) or anuric 4. Able to give informed consent
Exclusion criteria
1. Planned renal transplant within study intervention period 2. Planned conversion to peritoneal dialysis or transfer to another dialysis unit within study intervention period 3. Active chronic infection or significant active inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy 4. Life expectancy <12 months 5. Pregnancy or breast feeding 6. Indication for HDF according to treating physician 7. Dialysis catheter in situ 8. Receiving immunosuppressant medication 9. Current use of nutritional or dietary supplements to increase or reduce protein intake including protein powder or weight loss supplements and is unable to cease the supplement 10. Serum albumin <30g/L (within 4 weeks of screening) 11. Inability to complete study assessments
Outcome results
None listed