AnemiaPhase 4NCT01342640

A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 5 sites in Egypt.

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
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: 70 participants
Where: 5 sitesEgypt
Study dates: 18 Jul 2011to 30 Nov 2012
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

Adult patients, age >/=18 years
Diagnosis of chronic renal anemia
Not on dialysis
Hemoglobin concentration <10 g/dl
No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
Adequate iron status

Who cannot join

Transfusion of red blood cells during the previous 2 months
Poorly controlled hypertension
Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
Active malignant disease (except non-melanoma skin cancer)
Hemolysis
Hemoglobinopathies, e.g. sickle-cell disease, thalassemia

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Egypt5 sites

Mansoura Kidney Center; Nephrology
Al Mansurah, 0
Alexandria University; Endocrinology Department
Alexandria
El Qahira Al Fatemeya Hospital
Cairo
Kasr El Ainy University Hospital; Endocrinology Department
Cairo
Nasser Institute
Cairo

Other trials in Egypt

About this study

Official title: A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.

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
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.

Study groups in NCT01342640
Study group	Role	What they receive
Single Arm	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.

Change From Baseline in Mean Hb Concentration at Week 20
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
Measured: Baseline (Week 0), Week 20
Change From Baseline in Mean Hb Concentration at Week 24
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Measured: Baseline (Week 0), Week 24
Change From Baseline in Mean Hb Concentration at Week 28
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Measured: Baseline (Week 0), Week 28

Timeline

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

18 Jul 201130 Nov 2012

First posted27 Apr 2011 (estimated)
Study start18 Jul 2011
Primary completion30 Nov 2012
Study completion30 Nov 2012

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: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01342640
Sponsor's protocol ID: ML25300
Status last verified: Jun 2017
First submitted: 20 Apr 2011
Last updated: 12 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

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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Study at a glance

From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA
ClinicalTrials.gov ID: NCT01342640
Acronym / sponsor ID: ML25300
Conditions: Anemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 18 Jul 2011 (actual)
Primary completion: 30 Nov 2012 (actual)
Study completion: 30 Nov 2012 (actual)
First posted: 27 Apr 2011 (estimated)
Results: Posted 26 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	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 (7 listed)

Adult patients, age >/=18 years
Diagnosis of chronic renal anemia
Not on dialysis
Hemoglobin concentration <10 g/dl
No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start

Key exclusion criteria (6 listed)

Transfusion of red blood cells during the previous 2 months
Poorly controlled hypertension
Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
Active malignant disease (except non-melanoma skin cancer)
Hemolysis

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]Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.	Drug	Single Arm

Primary outcome

Change From Baseline in Mean Hb Concentration at Week 20
Time frame: Baseline (Week 0), Week 20
Per Protocol (PP) Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin less than or equal to [≤] 100 nanogram per milliliter [ng/mL] or mean transferrin saturation [TSAT] ≤20% or mean hypochromic red blood cells [RBCs] greater than or equal to [≥] 10% during efficacy evaluation period [Weeks 20 to 28]).
Change From Baseline in Mean Hb Concentration at Week 24
Time frame: Baseline (Week 0), Week 24
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).
Change From Baseline in Mean Hb Concentration at Week 28
Time frame: Baseline (Week 0), Week 28
PP Population: All participants in the safety population (all enrolled participants) except participants with less than 3 recorded Hb values in Weeks 20 to 28; who missed methoxy polyethylene glycol-epoetin beta dose in Weeks 20 to 28; who withdrew before efficacy evaluation period (Weeks 20 to 28); and participants with inadequate iron status (defined as mean serum ferritin ≤ 100 ng/mL or TSAT ≤20% or mean hypochromic RBCs ≥ 10% during efficacy evaluation period [Weeks 20 to 28]).

Results and safety

Results posted to the registry on 26 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methoxy Polyethylene Glycol-Epoetin Beta	70	29

Primary outcome: Change From Baseline in Mean Hb Concentration at Week 20

Time frame: Baseline (Week 0), Week 20. Mean (Standard Deviation). Unit: Grams per deciliter (gm/dL)

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 53
Baseline (n=53)	8.820 (0.736)
Change at Week 20 (n=35)	1.440 (1.144)

Methoxy Polyethylene Glycol-Epoetin Beta: p <0.0001, Paired t-test

Population analysed: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome and n signifies those participants who were evaluable for specified time-point.

Primary outcome: Change From Baseline in Mean Hb Concentration at Week 24

Time frame: Baseline (Week 0), Week 24. Mean (Standard Deviation). Unit: gm/dL

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 32
Value	1.470 (1.236)

Methoxy Polyethylene Glycol-Epoetin Beta: p <.0001, Paired t-test

Population analysed: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome.

Primary outcome: Change From Baseline in Mean Hb Concentration at Week 28

Time frame: Baseline (Week 0), Week 28. Mean (Standard Deviation). Unit: gm/dL

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 28
Value	1.680 (1.115)

Methoxy Polyethylene Glycol-Epoetin Beta: p <.0001, Paired t-test

Population analysed: PP Population. Here, number of participants analyzed (N) signifies those participants who were evaluable for this outcome

Adverse events

Time frame: From screening up to 32 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-Epoetin Beta	7 of 70 (10%)	7 of 70 (10%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
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

5 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 5 sites in Egypt.

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 7 inclusion and 6 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 12 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 5 sites in Egypt. 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 26 Oct 2015). 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?

Change From Baseline in Mean Hb Concentration at Week 20 (time frame: Baseline (Week 0), Week 20). The study lists 3 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 NCT01342640.

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 12 Jul 2017.