AnemiaPhase 4NCT01066000

A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 12 sites in Indonesia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

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]
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 12 sitesIndonesia
Study dates: 31 Oct 2009to 30 Sep 2011
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

Adults >/=18 years of age
Chronic renal anaemia
Haemoglobin concentration between 10 and 12 g/dL at screening
Adequate iron status
Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening
Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Who cannot join

Change in haemoglobin concentration >/=2 g/dL during screening
Transfusion of red blood cells less than 8 weeks prior to screening
Poorly controlled hypertension
Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
Active malignant disease
Haemolysis
Haemoglobinopathies

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Indonesia12 sites

Advent Hospital; Kidney and Hipertension
Bandung, 40131
Sanglah Hospital; Kidney and Hipertension
Denpasar, 80114
Rumah Sakit Pgi Cikini; Renal & Hypertension
Jakarta, 10330
Cipto Mangunkusumo Hospital; Renal and Hypertension division, Internal Medecine Department
Jakarta, 10440
Pelni Hospital; Kidney and Hipertension
Jakarta, 11410
Pondok Indah Hospital; Kidney and Hipertension
Jakarta, 12310
Pantai Indah Kapuk Hospital; Kidney and Hipertension
Jakarta, 14460
Klinik Spesialis Ginjal dan hipertensi Rasyida; Renal and Hypertension
Medan, 20119
Pirngadi; Renal and Hypertension
Medan, 20234
Telogorejo Hospital; Renal and Hypertension
Semarang, 50136
Dokter Soetomo Hospital
Surabaya, 60286
PHC Hospital; Renal and Hypertension
Surabaya, 60286

Other trials in Indonesia

About this study

Official title: A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.

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
initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly

Study groups in NCT01066000
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.

Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.
Measured: Up to Week 24

Secondary outcomes (7)

Number of Participants With Adverse Events and Serious Adverse Events
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. 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. The AEs were assessed from baseline to every visit throughout the treatment, post study drug discontinuation, and follow up period.
Measured: Up to Week 28
Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
The mean haemoglobin (Hb) concentration (g/dL) change from the baseline (Week 0) till efficacy evaluation period (EEP) was assessed and reported.
Measured: Up to Week 24
Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
The proportion of participants maintaining haemoglobin concentration within the haemoglobin range 10-12g/dL throughout the efficacy evaluation period (EEP) was assessed and reported.
Measured: Up to Week 24
Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
Mean time spent in the haemoglobin range 10 - 12 g/dL during the efficacy evaluation period (EEP) was assessed and reported.
Measured: Up to Week 24
Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
Mean number of months per participant requiring dose adjustment during the dose titration and evaluation periods was assessed and reported.
Measured: Up to Week 24
Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
Mean monthly dose of methoxy polyethylene glycol-epoetin beta during the dose titration and evaluation periods was assessed and reported.
Measured: Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20
Number of Participants With Marked Laboratory Abnormalities
A marked laboratory abnormality is defined as above and/or below the normal range of a laboratory parameter which was considered to be potentially clinically relevant. The number of participants with marked laboratory abnormality are presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: Haemoglobin (Hb) (11.7-17.3 g/dL), Haematocrit (Hct) (35-47%), White blood cells (WBC) (3.6-11.0 10^3/µL), Red blood cells (RBC) (3.8- 5.9 10^6/µL), MCV (80-100 fL) Platelets (150-440 10^3/µL), Iron (37-158 µg/dL), Ferritin (10-365 ng/mL), Transferrin (170-340 mg/dL), TIBC (250-450 µg/dL), TSAT (15-50%), Albumin (3.4-4.8 g/dL), hs-CRP (<= 10.000 mg/dL), Potassium (3.5-5.1 mmol/L), and Phosphorus (2.7-4.5 mg/dL).
Measured: Up to Week 28

Timeline

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

31 Oct 200930 Sep 2011

First posted10 Feb 2010 (estimated)
Study start31 Oct 2009
Primary completion30 Sep 2011
Study completion30 Sep 2011

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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01066000
Sponsor's protocol ID: ML21736
Status last verified: Nov 2017
First submitted: 9 Feb 2010
Last updated: 13 Nov 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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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm Open Label Interventional Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous Methoxy-polyethylene Glycol-epoetin Beta for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
ClinicalTrials.gov ID: NCT01066000
Acronym / sponsor ID: ML21736
Conditions: Anemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Terminated
Enrolment: 33 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Oct 2009 (actual)
Primary completion: 30 Sep 2011 (actual)
Study completion: 30 Sep 2011 (actual)
First posted: 10 Feb 2010 (estimated)
Results: Posted 13 May 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

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 (6 listed)

Adults >/=18 years of age
Chronic renal anaemia
Haemoglobin concentration between 10 and 12 g/dL at screening
Adequate iron status
Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening

Key exclusion criteria (7 listed)

Change in haemoglobin concentration >/=2 g/dL during screening
Transfusion of red blood cells less than 8 weeks prior to screening
Poorly controlled hypertension
Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening
Active malignant disease

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]initial doses of either 120 micrograms or 200 micrograms or 360 micrograms, once monthly	Drug	Mircera

Primary outcome

Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)
Time frame: Up to Week 24
The proportion of participants with their mean haemoglobin (Hb) concentration (g/dL) within the target range during the efficacy evaluation period was assessed. The target range is the reference Hb not >12 g/dL and not < 10 g/dL.

7 secondary outcomes

Number of Participants With Adverse Events and Serious Adverse Events
Time frame: Up to Week 28
Mean Change in Haemoglobin Concentration From Screening Period and Efficacy Evaluation Period
Time frame: Up to Week 24
Proportion of Participants Maintaining Haemoglobin Concentration Within the Haemoglobin Range 10-12g/dL Throughout the Efficacy Evaluation Period
Time frame: Up to Week 24
Mean Time Spent by Participants in the Haemoglobin Range of 10 - 12 g/dL During the Efficacy Evaluation Period
Time frame: Up to Week 24
Mean Number of Months Per Participant Requiring Dose Adjustment During the Dose Titration and Evaluation Periods
Time frame: Up to Week 24
Mean Monthly Dose of Methoxy Polyethylene Glycol-epoetin Beta During the Dose Titration and Evaluation Periods
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, and Week 20
Number of Participants With Marked Laboratory Abnormalities
Time frame: Up to Week 28

Results and safety

Results posted to the registry on 13 May 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
Mircera	33	24

Primary outcome: Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl)

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

Measure	Mircera n = 24
Value	45.8

Population analysed: Intent to treat (ITT) population was defined as all participants who entered study and took at least one dose of study drug. The ITT and safety population were identical. At Week 24, data of 24 participants were included whereas 9 participants were excluded from the analysis as they discontinued the study before analysis of this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mircera	4 of 33 (12.1%)	15 of 33 (45.5%)	Not reported

Limitations and caveats (from the sponsor): This was an open-label, single arm study with no control arms for comparison of results from this study. The study was prematurely terminated due to high screening failures and low recruitment rate. Therefore, the data only showed a trend.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
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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
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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

12 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 12 sites in Indonesia.

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 6 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: stopped early, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Indonesia. 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 13 May 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?

Proportion of Participants Maintaining Average Haemoglobin During the Efficacy Evaluation Period Within the Target Range (10-12 g/dl) (time frame: Up to Week 24). 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 NCT01066000.

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 13 Nov 2017.