AnemiaPhase 3NCT00442416
A Study of Subcutaneous Mircera for the Treatment of Anemia in Peritoneal Dialysis Patients.
A Phase 3 study testing Epoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 29 sites in United States.
Trial summary
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. 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 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
- 80 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2007to Jan 2008
- 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 kidney disease stage V;
- on peritoneal dialysis for 3 months prior to screening;
- on epoetin alfa sc >=3 months prior to screening.
Who cannot join
- patients expecting to change dialysis modality over course of study;
- patients hospitalized during previous 3 months for any clinically significant condition;
- active malignancy;
- bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
- transfusion of red blood cells within 3 months prior to screening.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Study site
Alexandria, Virginia, 22304
Study site
Augusta, Georgia, 30901
Study site
Bakersfield, California, 93309
Study site
Birmingham, Alabama, 35213
Study site
Chula Vista, California, 91910
Study site
Dayton, Ohio, 45408
Study site
Detroit, Michigan, 48236
Study site
Dyersburg, Tennessee, 38024
Study site
Flushing, New York, 11355
Study site
Lakewood, Colorado, 80214
Study site
Lewistown, Pennsylvania, 17044
Study site
Marietta, Georgia, 30060
Study site
Mountain View, California, 94041
Study site
Ocala, Florida, 34471
Study site
Pembroke Pines, Florida, 33028
Study site
Philadelphia, Pennsylvania, 19106
Study site
Pontiac, Michigan, 48341
Study site
Richmond, Virginia, 23229
Study site
San Antonio, Texas, 78215
Study site
San Leandro, California, 94578
Study site
Simi Valley, California, 93065
Study site
Stamford, Connecticut, 06902
Study site
Syracuse, New York, 13212
Study site
Toledo, Ohio, 43606
Study site
Tulsa, Oklahoma, 74120
Study site
Tyler, Texas, 75701
Study site
Whittier, California, 90602
Study site
Wichita, Kansas, 67214
Study site
Williamsville, New York, 14221
About this study
Official title: A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.
- Conditions
- Anemia
- Being tested
- Epoetin alfa, 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 alfaDrug
As prescribed, SC
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
120-360 micrograms SC monthly, starting dose
| Study group | Role | What they receive |
|---|---|---|
| RO0503821 | Experimental | Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so. Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
| Epoetin Alfa | Active comparator | Eligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so. Receives: Drug: Epoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.
Measured: From Baseline (D 0) to 9 months
Secondary outcomes (14)
Percentage of Participants With Safety-Related Hb Measures
Safety-related Hb measures included percentage of participants with Hb value > 13 g/dL, 13.5 g/dL, increase in Hb value from baseline by > 2 g/dL or decrease in Hb value from baseline by > 2 g/dL at any time during the study.
Measured: Up to Month 9
Number of Participants With Marked Laboratory Abnormalities
Participants with marked laboratory abnormalities in hematology and clinical chemistry parameters are reported. Hematology laboratory parameters included hematocrit fraction, hemoglobin, platelets, white blood cells (WBCs) and clinical chemistry parameters included aspartate aminotransferase ([AST], alanine aminotransferase ([ALT], creatine phosphokinase (CPK), alkaline phosphatase, albumin, potassium, fasting glucose and phosphate.
Measured: Up to Month 9
Mean Change From Baseline in Iron
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in iron to D1 of Months 2, 3, 4, 5, 6, 7, 8 is reported.
Measured: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Ferritin
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in ferritin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Measured: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Transferrin Saturation
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Measured: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Serum Transferrin
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in serum transferrin to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Measured: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Total Iron-binding Capacity
Adequate iron status is prerequisite to achieve and maintain target Hb levels. Mean change from Baseline (D 0) in total Iron-binding Capacity to D1 of M2, 3, 4, 5, 6, 7, and 8 is reported.
Measured: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Temperature
Measured: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Measured: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Pulse Rate
Measured: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Weight
Measured: From Baseline (D 0) to D1 and D15 of M7, M8
Number of Participants With Anti-erythropoietin Antibody in Human Serum
Erythropoietin is human protein which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with erythropoietin, anti-erythropoietin antibody (Anti-EPO) may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond to treatment. Number of participants with anti-EPO antibody that are quantifiable and those that were "below the limit of quantification (BLQ)" at Baseline (Day 0) and Visit 17 (Month 9 [M 9]) or final visit/early termination in human serum samples are reported.
Measured: Up to Month 9
Number of Participants With Anti-RO0503821 Antibody in Human Serum
RO0503821 is a chemically modified erythropoietin which helps to make more RBCs and is used for the treatment of anemia of chronic kidney disease. However, during treatment with RO0503821, anti-RO0503821 antibody may develop in human serum. These antibodies have been shown to cross-react with all ESAs and leads to failure to respond. Number of participants with anti- RO0503821 antibody that are quantifiable and those that were "BLQ" at Baseline (Day 0) and Visit 17 (M 9) or final visit/early termination in human serum samples are reported.
Measured: Up to Month 9
Number of Participants With Any AEs, Any Serious Adverse Events and Death
An AE is untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is with any of the following outcomes: Death, initial or prolonged inpatient hospitalisation, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: Strategic decision unrelated to safety or efficacy
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.
- 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
- 80 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
- NCT00442416
- Sponsor's protocol ID
- ML20338
- Status last verified
- Jul 2016
- First submitted
- 1 Mar 2007
- Last updated
- 17 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-arm, Randomized, Open-label, Multicenter Study of Safety and Efficacy of Monthly Injections of RO0503821 Versus Epoetin Alfa in Peritoneal Dialysis Patients Who Self Inject or Receive In-center Injections.
- ClinicalTrials.gov ID
- NCT00442416
- Acronym / sponsor ID
- ML20338
- Conditions
- Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision unrelated to safety or efficacy
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 2 Mar 2007 (estimated)
- Results
- Posted 17 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 2 arm study will compare the efficacy of monthly Mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. The safety of subcutaneous (sc) Mircera and injection site reactions and patient satisfaction will also be assessed. Eligible patients will be randomized either to receive monthly sc injections of Mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. Dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dL. The anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO0503821 | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]Eligible participants will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) will be based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses will be adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization will continue to do so. |
| Epoetin Alfa | Active comparator | Drug: Epoetin alfaEligible participants will be administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and will be followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization will continue to do so. |
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 kidney disease stage V;
- on peritoneal dialysis for 3 months prior to screening;
- on epoetin alfa sc >=3 months prior to screening.
Key exclusion criteria (5 listed)
- patients expecting to change dialysis modality over course of study;
- patients hospitalized during previous 3 months for any clinically significant condition;
- active malignancy;
- bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening;
- transfusion of red blood cells within 3 months prior to 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 |
|---|---|---|
| Epoetin alfaAs prescribed, SC | Drug | Epoetin Alfa |
| methoxy polyethylene glycol-epoetin beta [Mircera]120-360 micrograms SC monthly, starting dose | Drug | RO0503821 |
Primary outcome
Mean Change From Baseline in Hb Concentration to Average Over the Evaluation Period
Time frame: From Baseline (D 0) to 9 months
Mean change in Hb concentration from Baseline (Day [D] 0) to average during the evaluation period (Month 7 to 9) is reported.
14 secondary outcomes
Percentage of Participants With Safety-Related Hb Measures
Time frame: Up to Month 9
Number of Participants With Marked Laboratory Abnormalities
Time frame: Up to Month 9
Mean Change From Baseline in Iron
Time frame: From Baseline (D 0) to Month (M) 2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Ferritin
Time frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Transferrin Saturation
Time frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Serum Transferrin
Time frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Total Iron-binding Capacity
Time frame: From Baseline (D 0) to M2, M3, M4, M5, M6, M7, M8
Mean Change From Baseline in Temperature
Time frame: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Pulse Rate
Time frame: From Baseline (D 0) to D1 and D15 of M7, M8
Mean Change From Baseline in Weight
Time frame: From Baseline (D 0) to D1 and D15 of M7, M8
Number of Participants With Anti-erythropoietin Antibody in Human Serum
Time frame: Up to Month 9
Number of Participants With Anti-RO0503821 Antibody in Human Serum
Time frame: Up to Month 9
Number of Participants With Any AEs, Any Serious Adverse Events and Death
Time frame: Up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin alfa and methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 29 sites in United States.
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 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: stopped early, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. 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 17 Aug 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 From Baseline in Hb Concentration to Average Over the Evaluation Period (time frame: From Baseline (D 0) to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2016.