Chronic Kidney DiseaseMONITOR-CKD5NCT01121237
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
An observational study of Chronic Kidney Disease and End-stage Renal Disease, run by Sandoz at 95 sites in 10 countries.
Trial summary
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- What is being tested?
- Recombinant human erythropoietin alfa (biosimilar)
- How many people
- 2,086 participants
- Where
- 95 sitesin 10 countries
- Study dates
- Feb 2010to Nov 2014
- 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 with chronic kidney disease stage 5 with renal anemia and on haemodialysis
Who may be able to join
- Male or female adults (age > 18 years).
- On chronic haemodialysis due to end-stage renal disease (CKD5) of original or grafted kidneys for any duration.
- Diagnosed with renal anaemia; i.e., anaemia due to impaired production of endogenous erythropoietin secondary to kidney failure.
- Treated with commercially available intravenous EPOETIN ALFA HEXAL® per physician's best clinical judgment and under consideration of available guidance and evidence.
- Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
- Informed written consent to participate in the study by patients or their legal guardian.
Who cannot join
- Known sensitivity to EPOETIN ALFA HEXAL® or any other ESA.
- Solid or hematological neoplasia being treated with chemotherapy.
- Treatment with any myelosuppressant medications.
- Blood transfusion dependency.
- History of pure red cell aplasia.
- Bleeding episode in 30 days prior to enrollment.
Show all 12Show fewer
- Orthopaedic surgery in 30 days prior to enrollment.
- Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
- Patients with willfully negligent nonadherence to their haemodialysis, medication, nutrition, and/or other recommended treatment regimens.
- Use of any investigational agent in the 30 days prior to enrollment.
- Women of childbearing potential not using the contraception method(s) described above.
- Women who are breastfeeding.
Trial locations and contacts
95 sites in 10 countries.
95 sites in 10 countries
Germany37 sites
Sandoz Investigational Site
Alsfeld
Sandoz Investigational Site
Arnstadt
Sandoz Investigational Site
Bad Neustadt A. D. Saale
Sandoz Investigational Site
Bassum
Sandoz Investigational Site
Berlin
Sandoz Investigational Site
Bochum
Sandoz Investigational Site
Cloppenburg
Sandoz Investigational Site
Cochem
Sandoz Investigational Site
Darmstadt
Sandoz Investigational Site
Dresden
Sandoz Investigational Site
Duisburg
Sandoz Investigational Site
Düsseldorf
Sandoz Investigational Site
Erftstadt
Sandoz Investigational Site
Georgsmarienhütte
Sandoz Investigational Site
Greifswald
Sandoz Investigational Site
Güstrow
Sandoz Investigational Site
Herne
Sandoz Investigational Site
Herzberg
Sandoz Investigational Site
Höchstadt an der Aisch
Sandoz Investigational Site
Hoyerswerda
Sandoz Investigational Site
Kamen
Sandoz Investigational Site
Kiel
Sandoz Investigational Site
Magdeburg
Sandoz Investigational Site
Mettmann
Sandoz Investigational Site
Munich
Sandoz Investigational Site
Nuremberg
Sandoz Investigational Site
Osnabrück
Sandoz Investigational Site
Pinneberg
Sandoz Investigational Site
Quedlinburg
Sandoz Investigational Site
Remagen
Sandoz Investigational Site
Rendsburg
Sandoz Investigational Site
Schrobenhausen
Sandoz Investigational Site
Schwabach
Sandoz Investigational Site
Seehausen
Sandoz Investigational Site
Viersen
Sandoz Investigational Site
Wetzlar
Sandoz Investigational Site
Wilhelmshaven
Italy18 sites
Sandoz Investigational Site
Acireale
Sandoz Investigational Site
Altamura
Sandoz Investigational Site
Arenzano
Sandoz Investigational Site
Arezzo
Sandoz Investigational Site
Biella
Sandoz Investigational Site
Catania
Sandoz Investigational Site
Chivasso
Sandoz Investigational Site
Cinisello Balsamo
Sandoz Investigational Site
Cirié
Sandoz Investigational Site
Cosenza
Sandoz Investigational Site
Cuneo
Sandoz Investigational Site
Ivrea
Sandoz Investigational Site
Montevarchi
Sandoz Investigational Site
Pavia
Sandoz Investigational Site
Pontecorvo
Sandoz Investigational Site
Putignano
Sandoz Investigational Site
Roma
Sandoz Investigational Site
Torino
Romania9 sites
Sandoz Investigational Site
Bistriţa
Sandoz Investigational Site
Brăila
Sandoz Investigational Site
Brasov
Sandoz Investigational Site
Bucharest
Sandoz Investigational Site
Miercurea-Ciuc
Sandoz Investigational Site
Odorheiu Secuiesc
Sandoz Investigational Site
Reşiţa
Sandoz Investigational Site
Roman
Sandoz Investigational Site
TG. Jiu
Poland7 sites
Sandoz Investigational Site
Bialystok
Sandoz Investigational Site
Ciechanów
Sandoz Investigational Site
Gdansk
Sandoz Investigational Site
Lublin
Sandoz Investigational Site
Poznan
Sandoz Investigational Site
Rzeszów
Sandoz Investigational Site
Wołomin
Austria5 sites
Sandoz Investigational Site
Bregenz
Sandoz Investigational Site
Eisenstadt
Sandoz Investigational Site
Feldkirch
Sandoz Investigational Site
Nenzing
Sandoz Investigational Site
Vienna
France5 sites
Sandoz Investigational Site
Ajaccio
Sandoz Investigational Site
Dourlers
Sandoz Investigational Site
Fourmies
Sandoz Investigational Site
Lille
Sandoz Investigational Site
Saint-Quentin
Spain4 sites
Sandoz Investigational Site
Ávila
Sandoz Investigational Site
León
Sandoz Investigational Site
Seville
Sandoz Investigational Site
Zamora
Switzerland4 sites
Sandoz Investigational Site
Fribourg
Sandoz Investigational Site
Lausanne
Sandoz Investigational Site
Nyon
Sandoz Investigational Site
Zurich
United Kingdom4 sites
Sandoz Investigational Site
Cambridge
Sandoz Investigational Site
Chester
Sandoz Investigational Site
Norwich
Sandoz Investigational Site
Plymouth
Slovenia2 sites
Sandoz Investigational Site
Maribor
Sandoz Investigational Site
Sempeter pri Gorici
About this study
Official title: An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.
Read the detailed description
See the following publication:
Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Covic, A., Zaoui, P., Combe, C., Dellana, F., Muenzberg, M., \& Abraham, I. (in press). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine. (DOI 10.1007/511739-011-0622-7)
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- Being tested
- Recombinant human erythropoietin alfa (biosimilar)
- Keywords
- chronic kidney disease, end-stage renal disease, renal anaemia, epoetin alfa
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietin alfa (biosimilar)Drug
Also called biosimilar epoetin alfa
Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician
| Study group | Role | What they receive |
|---|---|---|
| CKD5, renal anaemia, haemodialysis | CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar) Receives: Drug: Recombinant human erythropoietin alfa (biosimilar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.
Measured: every month for 24 months
Secondary outcomes (1)
Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.
Safety will be assessed every month for 24 months. In addition, any safety events reported by the patient or observed by clinicians in-between the monthly assessments will be recorded at the time of report or occurrence, and will be addressed at that time as necessary.
Measured: Every month for 24 months + as occurring between visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- 2,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Responsible party
- Sponsor
- Investigators
- HEXAL AG, Study chair, Hexal AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121237
- Sponsor's protocol ID
- HX575-503
- Acronym
- MONITOR-CKD5
- Status last verified
- Apr 2016
- First submitted
- 6 May 2010
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrol. 2019 Mar 5;20(1):81. doi: 10.1186/s12882-019-1251-z.
PubMed 30836953Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.
PubMed 21590439
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
- ClinicalTrials.gov ID
- NCT01121237
- Acronym / sponsor ID
- MONITOR-CKD5 / HX575-503
- Conditions
- Chronic Kidney Disease, End-stage Renal Disease, Anaemia
- Keywords
- chronic kidney disease, end-stage renal disease, renal anaemia, epoetin alfa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,086 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Collaborators
- Hexal AG
- Study start
- Feb 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 May 2010 (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.
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.
Detailed description
See the following publication:
Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Covic, A., Zaoui, P., Combe, C., Dellana, F., Muenzberg, M., \& Abraham, I. (in press). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine. (DOI 10.1007/511739-011-0622-7)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD5, renal anaemia, haemodialysis | – | Drug: Recombinant human erythropoietin alfa (biosimilar)CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis
Key inclusion criteria (6 listed)
- Male or female adults (age > 18 years).
- On chronic haemodialysis due to end-stage renal disease (CKD5) of original or grafted kidneys for any duration.
- Diagnosed with renal anaemia; i.e., anaemia due to impaired production of endogenous erythropoietin secondary to kidney failure.
- Treated with commercially available intravenous EPOETIN ALFA HEXAL® per physician's best clinical judgment and under consideration of available guidance and evidence.
- Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
Key exclusion criteria (12 listed)
- Known sensitivity to EPOETIN ALFA HEXAL® or any other ESA.
- Solid or hematological neoplasia being treated with chemotherapy.
- Treatment with any myelosuppressant medications.
- Blood transfusion dependency.
- History of pure red cell aplasia.
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 |
|---|---|---|
| Recombinant human erythropoietin alfa (biosimilar)Also: biosimilar epoetin alfaRecombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician | Drug | CKD5, renal anaemia, haemodialysis |
Primary outcome
Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels.
Time frame: every month for 24 months
1 secondary outcome
Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.
Time frame: Every month for 24 months + as occurring between visits
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 6 Apr 2016.
- Derived from this study: PubMed 30836953Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrol. 2019 Mar 5;20(1):81. doi: 10.1186/s12882-019-1251-z.
- Derived from this study: PubMed 21590439Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.
- Individual participant dataSharing planned: Undecided
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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.
HEXAL AG study chair
Hexal AG
95 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and End-stage Renal Disease, run by Sandoz at 95 sites in 10 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 6 inclusion and 12 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 95 sites in Germany, Italy, Romania, Poland, Austria and 5 more countries. 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?
Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels. (time frame: every month for 24 months). 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 NCT01121237, which also lists 2 linked publications.
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 6 Apr 2016.