| Trial ID: | L0755 |
| Source ID: | NCT02301026
|
| Associated Drug: |
5% Iron Isomaltoside 1000
|
| Title: |
A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
|
| Acronym: |
DINO
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Anaemia in Chronic Kidney Disease
|
| Interventions: |
DRUG: 5% Iron Isomaltoside 1000
|
| Outcome Measures: |
Primary: Hb (Change in Hb compared to baseline at 3 months intervals), Change in Hb compared to baseline at 3 months intervals, 12 month | Secondary: Adverse drug reactions, 12 month|Adverse Events, 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, 12 month|ESA (use of ESA and dose), Use of ESA and dose, 12 month|Blood Transfusion (Number of blood transfusions), Number of blood transfusions, 12 month|IV iron dose (Total needed dose), Total needed dose, 12 month | Other: Nurse hours (time spend per treatment), Nurse time spend per treatment, 12 month
|
| Sponsor/Collaborators: |
Sponsor: Pharmacosmos A/S | Collaborators: BioStata
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
209
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2014-09-01
|
| Completion Date: |
2016-12-09
|
| Results First Posted: |
|
| Last Update Posted: |
2017-06-14
|
| Locations: |
Heleneholmsdialysen, Malmö, 214 30, Sweden|Morriston Hospital, Renal Department, Swansea, Wales, SA6 6NL, United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT02301026
|
