A single arm, non-randomised device trial to assess the effect of the Theranova Dialyser on albumin and uraemic solutes in patients with Stage V chronic kidney disease requiring haemodialysis

Phase 3

Completed

• Conditions: End Stage Kidney Disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12616000804482
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-21
• Study Completion: 2018-04-26
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in pre-dialysis concentrations of centrally tested serum albumin[At baseline and 6 months]