Anaemia in Chronic Kidney Disease
Conditions
Brief summary
The purpose of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in haemodialysis patients with Chronic Kidney Disease.
Detailed description
Parenteral iron is the iron treatment of choice for haemodialysis (HD) patients with Chronic Kidney Disease (CKD), who may suffer from absolute iron deficiency due to continuous blood losses and/or functional iron deficiency due to erythropoiesis stimulating agent treatment or impaired release from iron stores. Much evidence indicates that adequate iron supply is necessary to achieve optimal responses to ESAs and thereby potentially avoid ESA induced ADRs. Pharmacosmos has been working with dialysis providers for many years and identified a medical need for a new safe and cost-effective low dose intravenous (IV) iron that can be administered frequently. Diafer® is a new low dose iron formulation based on iron isomaltoside 1000, with doses restricted to maximum 200 mg iron pr. injection. No test dose is needed and Diafer® may be administered as a push injection. The primary objective of the study is to monitor initiated Diafer® therapy administered according to hospital practice and the product labeling in routine clinical practice in HD patients with CKD. The scientific rationale being to fulfil a need for systematic information/auditing on applied practice including long term experience with the use of IV iron in the HD setting. This information will provide an evidence base for optimised treatment procedures.
Interventions
DRUG5% Iron Isomaltoside 1000
Administered according to local routines and product labeling in doses at the doctors discretion
Sponsors
BioStata
Pharmacosmos A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HD patients ≥ 18 years of age in a stable phase of CKD as judged by the investigator * Patients must have been on HD \> 3 months * Patients must have received at least one dose of iron sucrose treatment within the last 6 months
Exclusion criteria
* Diafer® contraindications * Patient not able to give informed consent * Significant disease not related to CKD and likely to impact study results as evaluated by investigator * Inability to estimate retrospective baseline data * Planned change of iron dosing protocol or routines around iron administration during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hb (Change in Hb compared to baseline at 3 months intervals) | 12 month | Change in Hb compared to baseline at 3 months intervals |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug reactions | 12 month | — |
| Adverse Events | 12 month | AEs of special interest defined as hypersensitivity symptoms such as urticaria, oedema, bronchospasm, hypotension, cardiorespiratory arrest, syncope, unresponsiveness or loss of consciousness at pre-specified time points in relation to administration of study drug |
| Blood Transfusion (Number of blood transfusions) | 12 month | Number of blood transfusions |
| IV iron dose (Total needed dose) | 12 month | Total needed dose |
| ESA (use of ESA and dose) | 12 month | Use of ESA and dose |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nurse hours (time spend per treatment) | 12 month | Nurse time spend per treatment |
Countries
Sweden, United Kingdom
Outcome results
None listed