AnemiaPhase 3NCT00077623
A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.
A Phase 3 study testing epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta (Mircera) in people with Anemia, run by Hoffmann-La Roche at 90 sites in 21 countries.
Trial summary
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals. 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 alfa or beta 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
- 572 participants
- Where
- 90 sitesin 21 countries
- Study dates
- Mar 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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;
- on dialysis therapy for at least 12 weeks before screening;
- receiving sc epoetin for at least 8 weeks before screening.
Who cannot join
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
Trial locations and contacts
90 sites in 21 countries.
90 sites in 21 countries
United States17 sites
Study site
Boston, Massachusetts, 02130
Study site
Brooklyn Center, Minnesota, 55430
Study site
Dallas, Texas, 75216
Study site
Detroit, Michigan, 48202-2689
Study site
Hot Springs, Arkansas, 71901
Study site
Houston, Texas, 77030
Study site
Los Angeles, California, 90033
Study site
Morgantown, West Virginia, 26506
Study site
Portland, Oregon, 97210
Study site
Raleigh, North Carolina, 27609
Study site
Riverside, California, 92501
Study site
Sacramento, California, 95816-5119
Study site
San Antonio, Texas, 78229
Study site
San Jose, California, 95116-1906
Study site
Springfield, Massachusetts, 01107
Study site
Toledo, Ohio, 43606
Study site
Winston-Salem, North Carolina, 27157-1023
France12 sites
Study site
Bayonne, 64115
Study site
Boulogne, 62321
Study site
Cabestany, 66330
Study site
Caen, 14033
Study site
Limoges, 87042
Study site
Nîmes, 30029
Study site
Pantin, 93500
Study site
Poitiers, 86021
Study site
Saint-Germain-en-Laye, 78100
Study site
Saint-Priest-en-Jarez, 42055
Study site
Thionville, 57126
Study site
Tours, 37044
United Kingdom8 sites
Study site
Belfast, BT9 7LJ
Study site
Cambridge, CB2 2QQ
Study site
Dundee, DD1 9SY
Study site
Exeter, EX2 5DW
Study site
Leicester, LE5 4PW
Study site
London, SE1 9RT
Study site
London, SE22 8PT
Study site
London, SW17 0RE
Spain7 sites
Study site
Alcorcón, 28922
Study site
Barcelona, 08035
Study site
Madrid, 28006
Study site
Madrid, 28046
Study site
Palma de Mallorca, 07198
Study site
Pamplona, 31008
Study site
Santiago de Compostela, 15706
Italy6 sites
Study site
Cremona, 26100
Study site
Lecco, 23900
Study site
Mestre, 30174
Study site
Modena, 41100
Study site
Prato, 50047
Study site
Venezia, 30122
Hungary5 sites
Study site
Budapest, 1076
Study site
Budapest, 1134
Study site
Debrecen, 4032
Study site
Miskolc, 3526
Study site
Pécs, 7624
Belgium4 sites
Study site
Brussels, 1090
Study site
Edegem, 2650
Study site
Ghent, 9000
Study site
Hasselt, 3500
Poland4 sites
Study site
Gdansk, 80-211
Study site
Kielce, 25-736
Study site
Krakow, 31-501
Study site
Wroclaw, 50-417
Brazil3 sites
Study site
Curitiba, 81050-090
Study site
São Paulo, 03065-000
Study site
São Paulo, 04039-000
Czechia3 sites
Study site
Brno, 656 91
Study site
Ostrava, 708 52
Study site
Pilsen, 304 60
Finland3 sites
Study site
HUS, 00029
Study site
Tampere, 33521
Study site
Turku, 20521
Germany3 sites
Study site
Bad Hersfeld, 36251
Study site
Berlin, 12045
Study site
Kaiserslautern, 67655
Thailand3 sites
Study site
Bangkok, 10310
Study site
Bangkok, 10400
Study site
Phitsanulok, 65000
About this study
Official title: A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis
This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- epoetin alfa or beta, 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.
epoetin alfa or betaDrug
iv 3 times weekly, as prescribed
methoxy polyethylene glycol-epoetin beta (Mircera)Drug
60, 100 or 180 micrograms sc (starting dose) every 2 weeks
methoxy polyethylene glycol-epoetin beta (Mircera)Drug
60, 100 or 180 micrograms sc (starting dose) every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Experimental | Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the week preceding the switch to the study drug. Receives: Drug: methoxy polyethylene glycol-epoetin beta (Mircera) |
| RO0503821 (1x/4 Weeks) | Experimental | Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug. Receives: Drug: methoxy polyethylene glycol-epoetin beta (Mircera) |
| Epoetin Reference | Active comparator | Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks . Receives: Drug: epoetin alfa or beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Measured: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
Secondary outcomes (8)
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.
Measured: Evaluation period (Week 29 to Week 36)
Number of Participants With Red Blood Cell Transfusions
The number of participants who received RBC transfusions were reported.
Measured: Up to Week 36
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to week 52
Number of Participants With Marked Laboratory Abnormalities
A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10^9/L), platelets (100 - 550 10^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter [U/L]), alkaline phosphatase (ALP [0 - 220 U/L]), aspartate aminotransferase (ASAT) (0 - 80 U/L), albumin >= 30 g/L, phosphate (0.75 - 1.60 millimoles per liter [mmol/L]), potassium (2.9 - 5.8 mmol/L), glucose (2.80 - 11.10 mmol/L).
Measured: Up to week 52
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.
Measured: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.
Measured: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.
Measured: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.
Measured: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2004 (estimated)
- Study startMar 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- 572 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
- NCT00077623
- Sponsor's protocol ID
- BA16740
- Status last verified
- Apr 2016
- First submitted
- 10 Feb 2004
- Last updated
- 25 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
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 36791280
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis
- ClinicalTrials.gov ID
- NCT00077623
- Acronym / sponsor ID
- BA16740
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 13 Feb 2004 (estimated)
- Results
- Posted 26 Apr 2016
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 subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. 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
- 3
| Arm | Type | Receives |
|---|---|---|
| RO0503821 (1x/2 Weeks) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta (Mircera)Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the week preceding the switch to the study drug. |
| RO0503821 (1x/4 Weeks) | Experimental | Drug: methoxy polyethylene glycol-epoetin beta (Mircera)Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug. |
| Epoetin Reference | Active comparator | Drug: epoetin alfa or betaEligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients >=18 years of age;
- chronic renal anemia;
- on dialysis therapy for at least 12 weeks before screening;
- receiving sc epoetin for at least 8 weeks before screening.
Key exclusion criteria (2 listed)
- women who are pregnant, breastfeeding or using unreliable birth control methods;
- administration of another investigational drug within 4 weeks before screening, or during the study period.
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 |
|---|---|---|
| epoetin alfa or betaiv 3 times weekly, as prescribed | Drug | Epoetin Reference |
| methoxy polyethylene glycol-epoetin beta (Mircera)60, 100 or 180 micrograms sc (starting dose) every 2 weeks | Drug | RO0503821 (1x/2 Weeks) |
| methoxy polyethylene glycol-epoetin beta (Mircera)60, 100 or 180 micrograms sc (starting dose) every 4 weeks | Drug | RO0503821 (1x/4 Weeks) |
Primary outcome
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods
Time frame: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
8 secondary outcomes
Number of Participants Maintaining Average Hb Concentration During the Evaluation Period Within +-1 g/dL of Their Average Baseline Hb Concentration
Time frame: Evaluation period (Week 29 to Week 36)
Number of Participants With Red Blood Cell Transfusions
Time frame: Up to Week 36
Number of Participants With Any Adverse Events, Any Serious Adverse Events, and Deaths
Time frame: Up to week 52
Number of Participants With Marked Laboratory Abnormalities
Time frame: Up to week 52
Change From Baseline in Systolic and Diastolic Blood Pressure - at Weeks 36 and 52 in Hemodialysis Participants
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate at Weeks 36 and 52 in Hemodialysis Participants
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Systolic and Diastolic Blood Pressure at Weeks 36 and 52 in Peritoneal Dialysis Participants
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Change From Baseline in Pulse Rate - Peritoneal Dialysis Participants
Time frame: From Baseline (Week -4 to Week -1) to Week 36 and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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
90 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing epoetin alfa or beta and methoxy polyethylene glycol-epoetin beta (Mircera) in people with Anemia, run by Hoffmann-La Roche at 90 sites in 21 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 4 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 25 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, France, United Kingdom, Spain, Italy and 16 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?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Hemoglobin Concentration From Baseline to Evaluation Periods (time frame: Baseline (Week -4 to Week -1) and Evaluation period (Week 29 to Week 36)). 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 NCT00077623, 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 25 May 2016.