AnemiaNCT01695746

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage III-IV Chronic Kidney Disease Patients Not on Dialysis With Renal Anemia

An observational study of Anemia, run by Hoffmann-La Roche at 6 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in stage III-IV chronic kidney disease patients not on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Anemia
What is being tested?: C.E.R.A.
Type of treatment: Injection or infusion
How many people: 108 participants
Where: 6 sitesIndia
Study dates: Aug 2011to Nov 2013
Phase: Observational
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with Mircera for chronic renal anemia

Who may be able to join

Adult patients, 18 to 65 years of age, inclusive
Patients with stage III-IV chronic kidney disease not on dialysis
Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate iron status as judged by the treating physician

Who cannot join

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months
Pregnant women
Contraindications for Mircera according to local prescribing information or as judged by the investigator

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

India6 sites

Study site
Bhubaneswar, 751021
Study site
Hyderabad, 500 029
Study site
Mumbai, 400012
Study site
Mumbai, 400036
Study site
Vadodara, 390005
Study site
Vellore, 632006

Other trials in India

About this study

Official title: Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (C.E.R.A.) for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV, Not on Dialysis, Treated According to Routine Clinical Practice

Conditions: Anemia
Being tested: C.E.R.A.
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

C.E.R.A.Drug
Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.

Study groups in NCT01695746
Study group	Role	What they receive
C.E.R.A.		Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose. Receives: Drug: C.E.R.A.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Height of Participants at Baseline (Week 0)
The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
Measured: At Baseline (Week 0)
Mean Weight of Participants at Baseline (Week 0)
The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.
Measured: At Baseline (Week 0)
Number of Participants With Co-morbidities at Baseline (Week 0)
Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.
Measured: At Baseline (Week 0)
Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.
Measured: Up to Week 24
Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value
Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.
Measured: Up to Week 24

Secondary outcomes (6)

Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study
Correction of anemia was evaluated in participants with Hb < 10 g/dL at enrollment. Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The percentage of participants achieving the target Hb range (10-12 g/dL) at least once during the study is presented.
Measured: Up to Week 24
Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)
The Hb concentration was recorded for all the participants at enrollment and different time points throughout the study up to Week 24. The mean time spent (in weeks) by the participants in the target range (10 - 12 g/dL) is presented.
Measured: Up to Week 24
Mean Dose of C.E.R.A. Administered
The mean dose of C.E.R.A. administered during the study is reported. This accounts for the study drug injected through subcutaneous route at a frequency of every 4 weeks or once a month and every 2 weeks or fortnightly.
Measured: Up to Week 24
Number of Doses of C.E.R.A. Administered by Different Routes
The number of doses of C.E.R.A. administered by the intravenous or subcutaneous route is presented. The number of doses for total population is calculated by summation and presented in table below as per routes of administration.
Measured: Up to Week 24
Number of Participants Who Received Concomitant Treatment for Anemia
Medications that were used during the study treatment period (from the date of first dose of study medication to the end of the study) were included as concomitant medications. The number of participants taking concomitant medications prescribed for the treatment of anemia (for example iron) is presented.
Measured: Up to Week 24
Number of Participants With Adverse Events and Serious Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Pre-existing conditions which worsened during this study were reported as AEs. A serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
Measured: Up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2011Nov 2013

First posted28 Sep 2012 (estimated)
Study startAug 2011
Primary completionNov 2013
Study completionNov 2013

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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01695746
Sponsor's protocol ID: ML25476
Status last verified: Apr 2016
First submitted: 27 Sep 2012
Last updated: 2 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia trials

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: Efficacy of Methoxy Poly-Ethylene Glycol Epoetin Beta (C.E.R.A.) for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients in Stage III - IV, Not on Dialysis, Treated According to Routine Clinical Practice
ClinicalTrials.gov ID: NCT01695746
Acronym / sponsor ID: ML25476
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2011
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 28 Sep 2012 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
C.E.R.A.	–	Drug: C.E.R.A.Participants with chronic renal anemia Stage III-IV, not on dialysis, will be administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) according to routine clinical practice and will be followed up for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment will be at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label are - For correction of anemia: 0.6 microgram per kilogram (mcg/kg) of C.E.R.A. once every two weeks, and for Maintenance of hemoglobin (Hb) levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with stage III-IV chronic kidney disease not on dialysis receiving treatment with Mircera for chronic renal anemia

Key inclusion criteria (4 listed)

Adult patients, 18 to 65 years of age, inclusive
Patients with stage III-IV chronic kidney disease not on dialysis
Erythropoiesis stimulating agent (ESA) naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate iron status as judged by the treating physician

Key exclusion criteria (7 listed)

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months

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
C.E.R.A.Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.	Drug	C.E.R.A.

Primary outcome

Mean Height of Participants at Baseline (Week 0)
Time frame: At Baseline (Week 0)
The mean body height of the participants was measured and summarized in centimeters (cm). Baseline is defined as Week 0.
Mean Weight of Participants at Baseline (Week 0)
Time frame: At Baseline (Week 0)
The mean body weight of the participants was measured and summarized in kg. Baseline is defined as Week 0.
Number of Participants With Co-morbidities at Baseline (Week 0)
Time frame: At Baseline (Week 0)
Co-morbidities were those medical disorders present in the medical history but unresolved at Baseline. The number of participants with different co-morbidities is presented. Baseline is defined as Week 0.
Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)
Time frame: Up to Week 24
Correction of anemia was evaluated in participants with Hb < 10 gram/deciliter (g/dL). Hemoglobin levels were recorded for each participant at enrollment and at different time points during the study up to Week 24. The mean time required to achieve target Hb range (10-12 g/dL) was calculated using the following formula: Time to achieve target range = (Date of Hb evaluation when participant achieves target range at first time - visit date of first dosing) + 1.
Percentage of Participants Maintaining Hemoglobin Level Within 1 Gram/Deciliter of Baseline Value
Time frame: Up to Week 24
Maintenance of Hb levels was to be evaluated for participants on Erythropoiesis stimulating agent (ESA) with Hb levels 10-12 g/dL. None of the participants in the enrolled population had received treatment with other ESAs and had pre-therapy Hb level as 10 g/dL or above. Therefore, the percentage of participants who had received treatment with other ESAs and were maintaining Hb level within 1 g/dL of baseline value during the study could not be evaluated. Baseline is defined as Week 0.

6 secondary outcomes

Percentage of Participants Achieving Hemoglobin Target Range (10-12 Gram/Deciliter) at Least Once During the Study
Time frame: Up to Week 24
Mean Time Spent in the Hemoglobin Target Range (10 - 12 Gram/Deciliter)
Time frame: Up to Week 24
Mean Dose of C.E.R.A. Administered
Time frame: Up to Week 24
Number of Doses of C.E.R.A. Administered by Different Routes
Time frame: Up to Week 24
Number of Participants Who Received Concomitant Treatment for Anemia
Time frame: Up to Week 24
Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 2 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
C.E.R.A.	108	96

Primary outcome: Mean Height of Participants at Baseline (Week 0)

Time frame: At Baseline (Week 0). Mean (Standard Deviation). Unit: cm

Measure	C.E.R.A. n = 108
Value	163.15 (7.366)

Population analysed: The safety population included all participants entered into the study.

Primary outcome: Mean Weight of Participants at Baseline (Week 0)

Time frame: At Baseline (Week 0). Mean (Standard Deviation). Unit: kg

Measure	C.E.R.A. n = 108
Value	60.23 (9.618)

Population analysed: The safety population included all participants entered into the study.

Primary outcome: Number of Participants With Co-morbidities at Baseline (Week 0)

Time frame: At Baseline (Week 0). Number. Unit: Participants

Measure	C.E.R.A (Continuous Erythropoietin Receptor Activator) n = 108
Anaemia	2
Myocardial ischaemia	4
Congenital cystic kidney disease	1
Renal hypoplasia	1
Hypothyroidism	4
Liver disorder	1
Diabetes mellitus	18
Dyslipidaemia	1

Population analysed: The safety population included all participants entered into the study.

Primary outcome: Mean Time to Achieve Target Hemoglobin Range (10-12 Gram/Deciliter)

Time frame: Up to Week 24. Mean (Standard Deviation). Unit: Weeks

Measure	C.E.R.A. n = 83
Value	9.61 (6.130)

Population analysed: The intent-to-treat (ITT) population included all participants who received at least 1 dose of C.E.R.A. (Week 0), for whom data for at least one follow-up variable was available, and who did not have a major protocol violation. The participants who achieved target Hb range (10-12 g/dL) were included in the analysis.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 24. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C.E.R.A.	2 of 108 (1.9%)	2 of 108 (1.9%)	Not reported

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.

Related trials for Anemia

RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
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Not yet recruitingObservational study
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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

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, run by Hoffmann-La Roche at 6 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 4 inclusion and 7 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 6 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.

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 Height of Participants at Baseline (Week 0) (time frame: At Baseline (Week 0)). The study lists 5 primary outcomes in all. 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 NCT01695746.

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.