Evaluation of iron status in hemodialysis patients under maintenance therapy with intravenous iro

Not Applicable

Completed

• Conditions: End stage kidney disease on dialysis; Urological and Genital Diseases; Chronic kidney disease, stage 5

• Registration Number: ISRCTN12825165
• Lead Sponsor: Dr. med. A. Kistler

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30823916 results (added 10/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-02-28
• Study Start: 2019-02-01
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. Chronic hemodialysis patients receiving either 100 or 200 mg FCM every 4 weeks.
2. Age 18 years or older
3. HD treatment for at least three months
4. Thrice-weekly hemodialysis
5. Stable FCM dosing schedule for the last two months or longer
6. Stable erythropoietin stimulating agents (ESAs) for patients receiving ESAs (defined by dose adjustments of <25% within the last two months)
7. Haemoglobin values between 95g/l and 125g/l within the last 12 weeks with a difference between the lowest and the highest value of <15g/l.

Exclusion Criteria

1. Clinical evidence of significant blood loss within the last 12 weeks (e.g. gastrointestinal bleeding)
2. Significant inflammation (CRP >15 mg/l)
3. Hospital admission within the last month
4. Significant bacterial infection (e.g. pneumonia) within the last 12 weeks.

Study & Design

• Study Type: Observational
• Study Design: Not specified