Anaemia in Chronic Kidney DiseaseDINONCT02301026
A Non-interventional Study of Diafer in Subjects With CKD on Haemodialysis for Treatment of Iron Deficiency
An observational study of Anaemia in Chronic Kidney Disease, run by Pharmacosmos A/S at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaemia in Chronic Kidney Disease
- What is being tested?
- 5% Iron Isomaltoside 1000
- How many people
- 209 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2014to 9 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 18 years of age with chronic kidney disease (CKD) who have been on HD > 3 months and have received at least one dose of iron sucrose treatment within the last 6 months while being on dialysis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Morriston Hospital, Renal Department
Swansea, Wales, SA6 6NL
About this study
Official title: A Non-interventional Study of Diafer (5% Iron Isomaltoside 1000) Administered According to Standard Hospital Practice and Product Labelling in Subjects With Chronic Kidney Disease on Haemodialysis for Treatment of Iron Deficiency
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.
Read the 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.
- Conditions
- Anaemia in Chronic Kidney Disease
- Being tested
- 5% Iron Isomaltoside 1000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Iron Isomaltoside 1000Drug
Also called Diafer®
Administered according to local routines and product labeling in doses at the doctors discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb (Change in Hb compared to baseline at 3 months intervals)
Change in Hb compared to baseline at 3 months intervals
Measured: 12 month
Secondary outcomes (5)
Adverse drug reactions
Measured: 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
Measured: 12 month
ESA (use of ESA and dose)
Use of ESA and dose
Measured: 12 month
Blood Transfusion (Number of blood transfusions)
Number of blood transfusions
Measured: 12 month
IV iron dose (Total needed dose)
Total needed dose
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study start1 Sep 2014
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaemia in Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStata
- Responsible party
- Sponsor
- Investigators
- Sylvia Simon, Study chair, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301026
- Sponsor's protocol ID
- Diafer-NIS-06
- Acronym
- DINO
- Status last verified
- Apr 2017
- First submitted
- 13 Oct 2014
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Mikhail AI, Schon S, Simon S, Brown C, Hegbrant JBA, Jensen G, Moore J, Lundberg LDI. A prospective observational study of iron isomaltoside in haemodialysis patients with chronic kidney disease treated for iron deficiency (DINO). BMC Nephrol. 2019 Jan 10;20(1):13. doi: 10.1186/s12882-018-1159-z.
PubMed 30630452
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study of Diafer (5% Iron Isomaltoside 1000) Administered According to Standard Hospital Practice and Product Labelling in Subjects With Chronic Kidney Disease on Haemodialysis for Treatment of Iron Deficiency
- ClinicalTrials.gov ID
- NCT02301026
- Acronym / sponsor ID
- DINO / Diafer-NIS-06
- Conditions
- Anaemia in Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- BioStata
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years of age with chronic kidney disease (CKD) who have been on HD > 3 months and have received at least one dose of iron sucrose treatment within the last 6 months while being on dialysis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% Iron Isomaltoside 1000Also: Diafer®Administered according to local routines and product labeling in doses at the doctors discretion | Drug | – |
Primary outcome
Hb (Change in Hb compared to baseline at 3 months intervals)
Time frame: 12 month
Change in Hb compared to baseline at 3 months intervals
5 secondary outcomes
Adverse drug reactions
Time frame: 12 month
Adverse Events
Time frame: 12 month
ESA (use of ESA and dose)
Time frame: 12 month
Blood Transfusion (Number of blood transfusions)
Time frame: 12 month
IV iron dose (Total needed dose)
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Derived from this study: PubMed 30630452Mikhail AI, Schon S, Simon S, Brown C, Hegbrant JBA, Jensen G, Moore J, Lundberg LDI. A prospective observational study of iron isomaltoside in haemodialysis patients with chronic kidney disease treated for iron deficiency (DINO). BMC Nephrol. 2019 Jan 10;20(1):13. doi: 10.1186/s12882-018-1159-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Simon study chair
Pharmacosmos A/S
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anaemia in Chronic Kidney Disease, run by Pharmacosmos A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hb (Change in Hb compared to baseline at 3 months intervals) (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.