AnemiaPhase 3NCT00077597
A Study of Mircera for the Treatment of Anemia in Dialysis Patients
A Phase 3 study testing epoetin and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 59 sites in 13 countries.
Trial summary
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- epoetin and methoxy polyethylene glycol-epoetin beta [Mircera]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 59 sitesin 13 countries
- Study dates
- Feb 2004to Jun 2006
- Phase
- Phase 3
- 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
Who may be able to join
- adult patients >=18 years of age;
- chronic renal anemia;
- dialysis therapy for at least 2 weeks before screening.
Who cannot join
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 4 weeks before screening.
Trial locations and contacts
59 sites in 13 countries.
59 sites in 13 countries
United States14 sites
Study site
Atlanta, Georgia, 30342
Study site
Augusta, Georgia, 30901
Study site
Boston, Massachusetts, 02115
Study site
Burlington, Vermont, 05401
Study site
Davis, California, 95616
Study site
Detroit, Michigan, 48202-2689
Study site
Houston, Texas, 77054
Study site
Lakewood, Colorado, 80260
Study site
Mineola, New York, 11501
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10128
Study site
Norfolk, Virginia, 23507-1901
Study site
Springfield, Massachusetts, 01107
Study site
Toledo, Ohio, 43606
Canada9 sites
Study site
Calgary, Alberta, T2N 2T9
Study site
Kingston, Ontario, K7L 3N6
Study site
London, Ontario, N6A 5A5
Study site
Montreal, Quebec, H3A 1A1
Study site
Saskatoon, Saskatchewan, S7K 1N4
Study site
St. John's, Newfoundland and Labrador, A1B 3V6
Study site
Toronto, Ontario, M5G 2C4
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Winnipeg, Manitoba, R3A 1R9
Poland8 sites
Study site
Gdansk, 80-211
Study site
Gdynia, 81-519
Study site
Krakow, 31-501
Study site
Lodz, 90-153
Study site
Poznan, 60-355
Study site
Szczecin, 70-111
Study site
Wołomin, 05-200
Study site
Wroclaw, 50-417
Russia5 sites
Study site
Moscow, 123182
Study site
Moscow, 125101
Study site
Moscow, 129110
Study site
Saint Petersburg, 195067
Study site
Saint Petersburg, 197089
Brazil4 sites
Study site
Curitiba, 81050-090
Study site
Ribeirão Preto, 14025-170
Study site
São Paulo, 01307-001
Study site
São Paulo, 04039-000
Greece4 sites
Study site
Alexandroupoli, 68100
Study site
Larissa, 41 110
Study site
Nikaia, 18354
Study site
Thessaloniki, 54629
Thailand4 sites
Study site
Bangkok, 10700
Study site
Bangkok
Study site
Chiang Mai, 50200
Study site
Chon Buri
Czechia3 sites
Study site
Liberec, 460 63
Study site
Prague, 169 00
Study site
Ústí nad Labem, 401 13
About this study
Official title: A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- epoetin, methoxy polyethylene glycol-epoetin beta [Mircera]
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetinDrug
3 times a week iv, as prescribed.
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
0.4 micrograms/kg iv (starting dose) once every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| 2 | Active comparator | Not described Receives: Drug: epoetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin response rate
Measured: Weeks 1-24
Secondary outcomes (1)
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Measured: Throughout study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2004 (estimated)
- Study startFeb 2004
- Primary completionJun 2006
- Study completionJun 2006
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 AnemiaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077597
- Sponsor's protocol ID
- BA16736
- Status last verified
- Nov 2016
- First submitted
- 10 Feb 2004
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.
PubMed 18037099
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Study of the Effect of Intravenous Mircera on Hemoglobin Level/Correction in Dialysis Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT00077597
- Acronym / sponsor ID
- BA16736
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 12 Feb 2004 (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.
This study will assess the efficacy and safety of Mircera given intravenously in the treatment of renal anemia in chronic kidney disease patients on dialysis who are not currently receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| 2 | Active comparator | Drug: epoetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients >=18 years of age;
- chronic renal anemia;
- dialysis therapy for at least 2 weeks before screening.
Key exclusion criteria (2 listed)
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of any investigational drug within 4 weeks before screening.
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 |
|---|---|---|
| epoetin3 times a week iv, as prescribed. | Drug | 2 |
| methoxy polyethylene glycol-epoetin beta [Mircera]0.4 micrograms/kg iv (starting dose) once every 2 weeks | Drug | 1 |
Primary outcome
Hemoglobin response rate
Time frame: Weeks 1-24
1 secondary outcome
Hb over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, AEs, laboratory values\n
Time frame: Throughout study
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 2 Nov 2016.
- Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
- Derived from this study: PubMed 18037099Klinger M, Arias M, Vargemezis V, Besarab A, Sulowicz W, Gerntholtz T, Ciechanowski K, Dougherty FC, Beyer U. Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial. Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.
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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.
Clinical Trials study director
Hoffmann-La Roche
59 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 59 sites in 13 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 2 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Canada, Poland, Russia, Brazil and 8 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hemoglobin response rate (time frame: Weeks 1-24). 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 NCT00077597, 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 2 Nov 2016.