Table of contents
- Trial overview
- Who can participate
- What the study measures
- Study design and phase
- What the results may help understand
Trial overview
The available trial is a Phase 2 interventional study of SEVUPARIN in people with chronic kidney disease.[1] The study is authorised and plans to include 60 participants.[1]
Who can participate
This study is for subjects with chronic kidney disease.[1] The source data do not list more detailed entry rules, such as age limits, kidney test cutoffs, or other health requirements.[1]
What the study measures
The trial has two main parts.[1] In Part 1, researchers measure pharmacokinetic parameters, which show how SEVUPARIN moves through the body and is removed.[1] These measures include Cmax, tmax, AUC, terminal elimination half-life, and renal clearance.[1]
In Part 2, the study checks safety and tolerability by looking at adverse events, ECGs, vital signs, laboratory tests, urinalysis, and physical examinations.[1] The laboratory tests include serum biochemistry, haematology, reticulocytes, and coagulation parameters.[1] The brief summary also says the study will look at changes from baseline in blood and kidney-related measures linked to anaemia and kidney function after multiple subcutaneous doses of SEVUPARIN.[1]
Study design and phase
The study is designed to help build a nomogram, which is a chart or guide that links glomerular filtration rate (GFR, a measure of kidney filtering) with drug exposure.[1] This is meant to support individualised dosing in Part 2 based on GFR.[1] The intervention listed is SEVUPARIN given by subcutaneous use, and the source data describe a dose of 9 mg/kg.[1]
What the results may help understand
This trial is focused on whether SEVUPARIN can be studied safely in people with chronic kidney disease and how kidney function may affect drug levels in the body.[1] The results may also help researchers understand whether blood and kidney-related measures change after repeated dosing.[1]
