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Anakinra and Pioglitazone for Protein Energy Wasting in Hemodialysis
NCT02278562Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2014
- Primary completion
- Mar 2017
- Countries
- 1
- Sponsor
- VA Office of Research & Development
- Modality
- Cytokines & Interferons, Small Molecules
- Drugs
- anakinrapioglitazone
- Conditions
- protein-energy wasting (PEW)
01
Overview
Phase 2, randomised, double-blind trial in protein-energy wasting (PEW) comparing Anakinra, Pioglitazone and Placebo (3 arms). Primary endpoint: Change in Leucine Disposal Rate at 3 months. Started Oct 2014; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Anakinra
Anakinra SC + Placebo Oral
Pioglitazone
Pioglitazone Oral + Placebo SC
Placebo
Placebo SC + Placebo Oral
03
Who it enrols
Adult hemodialysis patients (>= 6 months on dialysis) with BMI 20-45, excluding those with active infection, cancer, liver disease, HIV, severe heart failure (NYHA III/IV), or diabetes on insulin.
04
Endpoints
Primary
Change in Leucine Disposal Rate
Secondary
Change in Whole-body Net Protein Balance
Change in Skeletal Muscle Net Protein Balance
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