End stage kidney disease on dialysis Urological and Genital Diseases Chronic kidney disease, stage 5
Conditions
Interventions
Patients taking part in this trial attend their normal dialysis schedule. At the beginning of the dialysis session before patients receive their regularly scheduled iron dose, blood is drawn to assess
Sponsors
Dr. med. A. Kistler
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change of serum ferritin from baseline to peak value. Serum ferritin is measured using an electrochemiluminescence method at baseline and at days 2,4,7,14,21 and 28. The values are compared using a two-sided paired t-test. 2. Change of transferrin saturation from baseline to peak value. Transferrin saturation (TSAT) is calculated from the serum iron and serum transferrin. Serum iron are measured using a spectrometry and serum transferrin is measured using an immunological agglutination assay at baseline and at days 2,4,7,14,21 and 28. The values are compared using a two-sided paired t-test. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to normalisation of ferritin and transferrin saturation (TSAT) values are calculated by comparing the ferritin and TSAT values of every time point assessed to the respective baseline values. Time to normalisation of ferritin and transferrin saturation (TSAT) values are defined as 1.1. The time when the mean values are no longer different from baseline 1.2. When ferritin and TSAT values are 75% of patients. 2. Change of ferritin and TSAT for every time point assessed is calculated and compared using a two-sided paired t-test. 3. Changes in other laboratory parameters are calculated and compared to their baseline values using a two-sided paired t-test for every time point. | — |
Countries
Switzerland
Contacts
Public ContactMatthias Diebold
Outcome results
None listed