AnemiaPhase 4NCT00737711
A Study of Two-Weekly Intravenous Mircera for the Treatment of Dialysis Patients With Chronic Renal Anemia Not Receiving ESA Therapy.
A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 16 sites in India.
Trial summary
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- What is being tested?
- 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
- 189 participants
- Where
- 16 sitesIndia
- Study dates
- Jul 2008to Oct 2009
- Phase
- Phase 4
- 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
- male or female patients, >=18 years of age;
- chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- no prior erythropoietin stimulating agent (ESA) therapy.
Who cannot join
- blood transfusion within the previous 4 weeks;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
India16 sites
Study site
Ahmedabad, 380007
Study site
Bangalore, 560034
Study site
Chennai, 603103
Study site
Coimbatore, 641004
Study site
Gujarat, 387 001
Study site
Hyderabad, 500001
Study site
Kerala, 682017
Study site
Kolkata, 700099
Study site
Ludhiana
Study site
Mumbai, 400026
Study site
Mumbai
Study site
New Delhi, 110 060
Study site
New Delhi, 110017
Study site
New Delhi, 110026
Study site
Vellore, 632 004
Study site
Vishakpatnam, 530002
About this study
Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
- Conditions
- Anemia
- Being tested
- 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.
methoxy polyethylene glycol-epoetin beta [Mircera]Drug
iv 0.6 micrograms/kg every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mircera | Experimental | Not described Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
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 Week 16 of the Treatment Period
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
Measured: Baseline (Week 0) and Week 16
Secondary outcomes (27)
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Achievement of blood Hb levels within target range of 10.0-12.0 g/dL was considered as achievement of response. The mean time required to achieve the Hb target range is presented in weeks.
Measured: Up to Week 16
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The mean time spent (in weeks) by the participants in the target range (10-12 g/dL) during the last 4 weeks of the TP is presented.
Measured: Week 12 to Week 16
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 16. The percentage of participants achieving Hb levels within target range of 10.0-12.0 g/dL during the last 4 weeks of the TP is presented.
Measured: Week 12 to Week 16
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. An SAE is any AE that can result in death or is life-threatening or required participant hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above
Measured: Up to Week 18
Number of Participants With Abnormal Electrocardiogram
Twelve-lead electrocardiogram (ECG) was recorded for the participants. The number of participants with abnormal ECG is presented.
Measured: Up to Week 16
Number of Participants With Reports of Blood Transfusions
Indications for blood transfusions were acute blood loss (bleeding), lack of treatment response or treatment failure, or other reasons.
Measured: Up to Week 16
Number of Participants With Reports of Anti-Epoetin Antibodies
Participants were assessed for the presence of Anti-Epoetin antibodies for MIRCERA.
Measured: Up to Week 16
Mean White Blood Cell Count Over Time
The mean values of white blood cells are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Value of Mean Corpuscular Volume Over Time
Mean corpuscular volume (MCV) is a measure of the average volume of red blood corpuscles (RBCs) and is calculated by dividing hematocrit value by the concentration of RBCs. Mean values of MCV are presented at Baseline (Week 0), Week 4, Week 10, and Week 16. Reference range of mean corpuscular volume is 80-96 femtoliter (fL) per red blood cell.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Hypochromic Red Blood Cells Over Time
Mean values of hypochromic RBCs are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Platelet Count Over Time
Mean values of platelet count are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Iron Over Time
Mean values of serum iron are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Ferritin Over Time
Mean values of serum ferritin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Over Time
Mean values of serum transferrin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Total Iron-binding Capacity Over Time
Mean values of total iron-binding capacity are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Saturation Over Time
Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is calculated as serum iron/ total iron-binding capacity x 100. Mean values of transferrin saturation at Baseline (Week 0), Week 4, Week 10, and Week 16 are presented.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Albumin Over Time
Mean values of serum albumin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Globulin Over Time
Mean values of serum globulin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Creatinine Over Time
Mean values of serum creatinine are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Blood Urea Nitrogen Over Time
Mean values of blood urea nitrogen (BUN) are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Potassium Over Time
Mean values of serum potassium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Sodium Over Time
Mean values of serum sodium are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Phosphate Over Time
Mean values of serum phosphate are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Bilirubin Over Time
Mean values of serum bilirubin are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Aspartate Transaminase Over Time
Mean values of aspartate transaminase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Alanine Aminotransferase Over Time
Mean values of alanine aminotransferase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Alkaline Phosphatase Over Time
Mean values of serum alkaline phosphatase are presented at Baseline (Week 0), Week 4, Week 10, and Week 16.
Measured: Baseline (Week 0), Week 4, Week 10, and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2009
- Study completionOct 2009
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 189 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
- NCT00737711
- Sponsor's protocol ID
- ML21822
- Status last verified
- Apr 2016
- First submitted
- 18 Aug 2008
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Two Weekly Administration of Intravenous Methoxy Polyethylene Glycol-epoetin Beta (MIRCERA) for the Treatment of Chronic Renal Anemia in Dialysis Patients Not Currently Treated With Erythropoietin-stimulating Agent (ESA).
- ClinicalTrials.gov ID
- NCT00737711
- Acronym / sponsor ID
- ML21822
- Conditions
- Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 19 Aug 2008 (estimated)
- Results
- Posted 2 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single arm study will evaluate the hemoglobin (Hb) increasing effect, safety and tolerability of two-weekly intravenous administration of Mircera in dialysis patients with chronic renal anemia not currently treated with ESAs. Patients will receive intravenous Mircera 0.6 micrograms/kg every 2 weeks for 16 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mircera | Experimental | Drug: methoxy polyethylene glycol-epoetin beta [Mircera] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- male or female patients, >=18 years of age;
- chronic renal anemia (Hb concentration 8.0g/dL - 10.0g/dL);
- no prior erythropoietin stimulating agent (ESA) therapy.
Key exclusion criteria (5 listed)
- blood transfusion within the previous 4 weeks;
- poorly controlled hypertension;
- significant acute or chronic bleeding;
- active malignant disease;
- congestive heart failure (NYHA Class IV).
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 |
|---|---|---|
| methoxy polyethylene glycol-epoetin beta [Mircera]iv 0.6 micrograms/kg every 2 weeks | Drug | Mircera |
Primary outcome
Mean Change in Hemoglobin Concentration From Baseline to Week 16 of the Treatment Period
Time frame: Baseline (Week 0) and Week 16
The difference between the mean Hemoglobin (Hb) value at the last visit (Week 16) of the treatment period (TP) and at Baseline (Week 0) is presented. TP was from Baseline to Week 16.
27 secondary outcomes
Mean Time Required to Achieve Blood Hemoglobin Levels Within Target Range of 10.0-12.0 Gram/Deciliter
Time frame: Up to Week 16
Mean Time Spent in the Hemoglobin Range of 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Time frame: Week 12 to Week 16
Percentage of Participants With Average Hemoglobin Concentration Between 10.0-12.0 Gram/Deciliter From Week 12 to Week 16
Time frame: Week 12 to Week 16
Number of Participants With Adverse Events, Serious Adverse Events and Deaths
Time frame: Up to Week 18
Number of Participants With Abnormal Electrocardiogram
Time frame: Up to Week 16
Number of Participants With Reports of Blood Transfusions
Time frame: Up to Week 16
Number of Participants With Reports of Anti-Epoetin Antibodies
Time frame: Up to Week 16
Mean White Blood Cell Count Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Value of Mean Corpuscular Volume Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Hypochromic Red Blood Cells Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Platelet Count Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Iron Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Ferritin Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Total Iron-binding Capacity Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Transferrin Saturation Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Albumin Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Globulin Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Creatinine Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Blood Urea Nitrogen Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Potassium Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Sodium Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Phosphate Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Bilirubin Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Aspartate Transaminase Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Alanine Aminotransferase Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Mean Serum Alkaline Phosphatase Over Time
Time frame: Baseline (Week 0), Week 4, Week 10, and Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
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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
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 16 sites in India.
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 2 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 2 Jun 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 Week 16 of the Treatment Period (time frame: Baseline (Week 0) and Week 16). 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 2 Jun 2016.