AnemiaOPTIMANCT01902628

OPTIMA: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Participants With Chronic Kidney Disease Stages 3 and 4 Not on Dialysis

An observational study of Anemia, run by Hoffmann-La Roche at 24 sites in Greece.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
How many people: 437 participants
Where: 24 sitesGreece
Study dates: 15 Jul 2013to 4 Sep 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4) initiated on Mircera therapy

Who may be able to join

Adult participants, >/= 18 years of age
Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4)
Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
Life expectancy > 10 months

Who cannot join

Malignant disease
Significant or acute bleeding
Poorly controlled hypertension
Blood transfusion during the previous 2 months
Hypersensitivity to Mircera or any of its excipients

Trial locations and contacts

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

Greece24 sites

Uni Hospital of Alexandroupoli; Nephrology Dept.
Alexandroupoli, 68100
Laiko General Hospital; Nephrology Div.
Athens, 115 27
Red Cross Hospital;Nephrology Dpt.
Athens, 11526
General Hospital Of Athens G.Gennimatas; Nephrology
Athens, 11527
Ippokrateion Gen. Hospital Of Athens; 2nd University Clinic Of Internal Medicine, Diabetes Center
Athens, 11527
Kyanos Stavros Private Hospital; Nephrologic Clinic
Athens, 11528
General Hospital Of West Attikis; Nephrology
Athens, 12351
University Hospital Attikon ; Pathology Clinic
Athens, 124 61
Nikea General Hospital; Nephrologic Clinic
Athens, 18454
General Hospital Of Dramas; Dialysis Center Unit
Drama, 66100
University Hospital Of Heraklion; Nefrologiki Clinic
Heraklion, 71110
Uni Hospital of Ioannina; Nephrology Dept.
Ioannina, 455 00
General Hospital Of Katerinis; Nephrology Unit
Katerini
General Hospital of Kilkis; Nephrology
Kilkis, 611 00
Univeristy Hospital of Larissa; Nephrology
Larissa, 41 110
Agios Andreas General Hospital; Nephrology
Pátrai, 26335
Olympion Therapeytirion; Nefrology
Pátrai, 26443
General Hospital Tzanio ; Nephrology
Piraeus, 18536
General Hospital Of Serres; Nephrology
Serres, 62100
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, 54636
Thermi Private Clinic; Nephrology
Thessaloniki, 570 01
Agios Loukas Private Clinic; Nephrology
Thessaloniki
Thessaliki Nossileytiki; Nephrology
Volos, 38221
General Hospital of Xanthi; Nephrology
Xánthi

Other trials in Greece

About this study

Official title: An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)

This prospective observational study evaluated the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease participants on dialysis with renal anemia. Participants initiated on treatment with Mircera according to the Summary of Product Characteristics and standard clinical practice were followed for 10 months.

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 NCT01902628
Study group	Role	What they receive
Participants with CKD		This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.

What is being measured

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

Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
g/dL = grams per deciliter
Measured: Months 8 to 10

Secondary outcomes (3)

Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
g/dL = grams per deciliter
Measured: Months 8 to 10
Percentage of Participants With MIRCERA Dose Adjustments
Changes in Mircera dose since last visit are reported. The numbers of participants for which data were not reported are also indicated.
Measured: Up to 10 months
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug. A serious AE is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
Measured: Up to 10 months

Timeline

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

15 Jul 20134 Sep 2016

First posted18 Jul 2013 (estimated)
Study start15 Jul 2013
Primary completion4 Sep 2016
Study completion4 Sep 2016

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: 437 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01902628
Sponsor's protocol ID: ML28261
Acronym: OPTIMA
Status last verified: Aug 2019
First submitted: 16 Jul 2013
Last updated: 9 Aug 2019
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 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational, Prospective Study to Evaluate the Hemoglobin Levels in Non-Dialysis Chronic Kidney Disease Subjects With Renal Anemia, Treated With MIRCERA (Methoxy-Polyethylene-Glycol-Epoetin Beta)
ClinicalTrials.gov ID: NCT01902628
Acronym / sponsor ID: OPTIMA / ML28261
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 437 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 15 Jul 2013 (actual)
Primary completion: 4 Sep 2016 (actual)
Study completion: 4 Sep 2016 (actual)
First posted: 18 Jul 2013 (estimated)
Results: Posted 7 Aug 2018

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
Participants with CKD	–	–This single cohort included participants with CKD not receiving dialysis (Stages 3 and 4), with renal anemia, treated with MIRCERA according to usual clinical practice.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4) initiated on Mircera therapy

Key inclusion criteria (4 listed)

Adult participants, >/= 18 years of age
Participants with chronic kidney disease (CKD) not on dialysis with renal anemia (CKD Stages 3 \& 4)
Initiated on Mircera treatment (participants may have received Mircera treatment for up to 3 months before study enrollment)
Life expectancy > 10 months

Key exclusion criteria (5 listed)

Malignant disease
Significant or acute bleeding
Poorly controlled hypertension
Blood transfusion during the previous 2 months
Hypersensitivity to Mircera or any of its excipients

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

Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10
Time frame: Months 8 to 10
g/dL = grams per deciliter

3 secondary outcomes

Percentage of Participants With Hemoglobin Levels Within the Following Ranges: 11.0 - 12.0 g/dL, 11.0 - 13.0 g/dL, and 10.0 - 13.0 g/dL at Months 8-10
Time frame: Months 8 to 10
Percentage of Participants With MIRCERA Dose Adjustments
Time frame: Up to 10 months
Number of Participants With Serious Adverse Events (AEs) and Non-Serious AEs
Time frame: Up to 10 months

Results and safety

Results posted to the registry on 7 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants With CKD	437	354

Primary outcome: Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10

Time frame: Months 8 to 10. Number. Unit: percentage of participants

Measure	Participants With CKD n = 437
Value	51.2

Population analysed: The intent-to-treat population included all eligible participants who received at least one dose of MIRCERA during the observational period, and who had evaluable data.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 10 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants With CKD	56 of 437 (12.8%)	37 of 437 (8.5%)	Not reported

Limitations and caveats (from the sponsor): Study limitations include the absence of a control group and the observational design of the study. In addition, differences between subgroups found in non-interventional studies cannot be used to infer causality.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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

24 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 24 sites in Greece.

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: finished, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Greece. 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 7 Aug 2018). 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?

Percentage of Participants With Hemoglobin Levels Within 10.0 - 12.0 g/dL at Months 8-10 (time frame: Months 8 to 10). 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 NCT01902628.

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 9 Aug 2019.