AnemiaNCT01677767

An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

An observational study of Anemia, run by Hoffmann-La Roche at 7 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 chronic kidney disease patients 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
How many people: 127 participants
Where: 7 sitesIndia
Study dates: 30 Apr 2011to 30 Sep 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 chronic kidney disease 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 chronic kidney disease on dialysis
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 irons 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

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

India7 sites

Ahmedabad Dialysis Centre
Ahmedabad, 380005
Excel Center
Guwahati, 781007
ESIS Hospital; Department of Nephrology
Kolkata, 600054
Vertex Hospital
Mumbai, 400083
Sir Gangaram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Apollo Indraprastha Hospitals; Nephrology
New Delhi, 110076
Aditya Birla Memorial Hospital
Pune, 411033

Other trials in India

About this study

Official title: Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

Conditions: Anemia
Medical subject headings: Anemia

What participants receive

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

Study groups in NCT01677767
Study group	Role	What they receive
Cohort		Not described

What is being measured

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

Mean Age of Participants Treated With C.E.R.A
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
Measured: Baseline (Week 0)
Mean Weight of Participants Treated With C.E.R.A
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
Measured: Baseline (Week 0)
Number of Participants With Co-morbidity Treated With C.E.R.A
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
Measured: Up to Week 24
Mean Time Required to Achieve Target Hemoglobin Range
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
Measured: Up to Week 24
Percentage of Participants Achieved Target Range of Hemoglobin
The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
Measured: Up to Week 24
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.
Measured: Up to Week 24

Secondary outcomes (5)

Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
Measured: Up to Week 24
Mean Time Spent by Participants in the Hb Target Range
Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.
Measured: Up to Week 24
Evaluation of Route of Administration for C.E.R.A
C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.
Measured: Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A
The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.
Measured: Up to Week 24
Number of Participants Received Concomitant Medications
Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.
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.

30 Apr 201130 Sep 2013

First posted3 Sep 2012 (estimated)
Study start30 Apr 2011
Primary completion30 Sep 2013
Study completion30 Sep 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: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01677767
Sponsor's protocol ID: ML25475
Status last verified: May 2017
First submitted: 30 Aug 2012
Last updated: 5 Jul 2017
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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Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
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RecruitingObservational study
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice
ClinicalTrials.gov ID: NCT01677767
Acronym / sponsor ID: ML25475
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 30 Apr 2011 (actual)
Primary completion: 30 Sep 2013 (actual)
Study completion: 30 Sep 2013 (actual)
First posted: 3 Sep 2012 (estimated)
Results: Posted 5 Feb 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
Cohort	–	–

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic kidney disease 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 chronic kidney disease on dialysis
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 irons 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.

Primary outcome

Mean Age of Participants Treated With C.E.R.A
Time frame: Baseline (Week 0)
Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
Mean Weight of Participants Treated With C.E.R.A
Time frame: Baseline (Week 0)
Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
Number of Participants With Co-morbidity Treated With C.E.R.A
Time frame: Up to Week 24
Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.
Mean Time Required to Achieve Target Hemoglobin Range
Time frame: Up to Week 24
The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1
Percentage of Participants Achieved Target Range of Hemoglobin
Time frame: Up to Week 24
The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants.
Time frame: Up to Week 24
Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.

5 secondary outcomes

Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
Time frame: Up to Week 24
Mean Time Spent by Participants in the Hb Target Range
Time frame: Up to Week 24
Evaluation of Route of Administration for C.E.R.A
Time frame: Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A
Time frame: Up to Week 24
Number of Participants Received Concomitant Medications
Time frame: Up to Week 24

Results and safety

Results posted to the registry on 5 Feb 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.	124	102

Primary outcome: Mean Age of Participants Treated With C.E.R.A

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

Measure	C.E.R.A. n = 124
Value	48.1 (12.26)

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

Primary outcome: Mean Weight of Participants Treated With C.E.R.A

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

Measure	C.E.R.A. n = 119
Value	57.44 (13.269)

Population analysed: The safety population included all participants enrolled into the study. The analysis population reflects those participants whose weights were assessed at baseline.

Primary outcome: Number of Participants With Co-morbidity Treated With C.E.R.A

Time frame: Up to Week 24. Number. Unit: Number of participants

Measure	C.E.R.A. n = 124
Total comorbid participants	107
Comorbidity, renal and urinary disorders	63
Comorbidity, vascular disorders	61
Comorbidity, metabolism and nutrition disorders	46

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

Primary outcome: Mean Time Required to Achieve Target Hemoglobin Range

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

Measure	C.E.R.A. n = 95
Value	11.66 (5.652)

Population analysed: ITT population included all the participants who received at least 1 dose of C.E.R.A (Week 0) and for whom data for at least one follow-up variable was available. The analysis population reflects those participants whose Hb value was less than (\<) 10 g/dL at enrollment.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 24. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
C.E.R.A.	6 of 124 (4.8%)	21 of 124 (16.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2017.
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
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome

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

7 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 7 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 5 Feb 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 Age of Participants Treated With C.E.R.A (time frame: Baseline (Week 0)). The study lists 6 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 NCT01677767.

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 5 Jul 2017.