AnemiaPhase 4NCT00737464

A Study of Once Monthly Intravenous Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.

A Phase 4 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 17 sites in India.

Completed

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

Official record

Search all trials

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: 132 participants
Where: 17 sitesIndia
Study dates: 26 Aug 2008to 12 Sep 2009
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

male or female patients, >=18 years of age;
chronic renal anemia;
Hb concentration 10.5g/dL - 12.5g/dL;
continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Who cannot join

blood transfusion within the previous 2 months;
poorly controlled hypertension;
significant acute or chronic bleeding;
active malignant disease;
congestive heart failure (NYHA Class IV).

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

India17 sites

Manipal Institute of Nephrology and Urology; Nephrology
Bangalore, 560017
Columbia Asia Medical Centre - Hebbal; Nephrology
Bangalore, 560024
Tanker Foundation
Chennai, 600 037
MIOT Institute of Nephrology ; Nephrology
Chennai, 6000089
Madras Medical Mission Hospital
Chennai, 600037
International Hospital
Guwahati, 781005
Kamineni Hospitals; Nephrology
Hyderabad, 500068
Nizam's Institute of Medical Sciences; Nephrology
Hyderabad, 500082
Regency Hospital Ltd.; Nephrology
Kanpur, 208005
Wockhardt Hospital and Kidney Institute; Nephrology
Kolkata, 700029
Meerut Kidney Hospital
Meerut, 250001
Silver Oaks Hospital; Nephrology
Mohali, 160 063
Apex Kidney Care
Mumbai, 400080
Lancelot Dialysis Center
Mumbai, 400092
Indraprastha Apollo Hospitals
New Delhi, National Capital Territory of Delhi, 110076
Fortis Flt. Lt. Rajan Dhall Hospital; Nephrology
New Delhi, 110070
Ruby Hall Clinic
Pune, 411 001

Other trials in India

About this study

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

This single arm study will evaluate the maintenance of hemoglobin levels, safety and tolerability of once-monthly intravenous administration of Mircera in dialysis patients with chronic renal anemia. Patients will receive intravenous Mircera (120, 200 or 360 micrograms) every four weeks depending on the previous dose of epoetin alfa administered in the week preceding first study drug administration. Patients will be treated for 12 weeks with follow up 2 weeks after the last treatment visit. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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
iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.

Study groups in NCT00737464
Study group	Role	What they receive
Mircera	Experimental	Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks. 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.

Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Measured: Weeks 8 to 12 (Last 4 weeks of treatment period)

Secondary outcomes (17)

Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
The mean change in Hb concentration between reference stability verification period (SVP) and in last 4 weeks (Weeks 8 to 12) of treatment period (TP) was reported. Duration for SVP was 2 weeks followed by treatment period of 12 weeks. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.
Measured: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Mean time participants spent having hemoglobin range of 10.0 to 12.0 g/dL was reported. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value hemoglobin +/- 1 gram per deciliter but not >12.0 g/dL and not <10.0 g/dL.
Measured: Up to Week 12
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and deaths in the overall study were reported. An Adverse Event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Measured: Up to Week 14
Mean Change From Baseline in Heart Rate Over Time
Mean change from Baseline (Week -1) to end of the treatment (Week 12) in heart rate was reported. Baseline measure was considered as (Week -1) evaluation for this parameter.
Measured: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Mean change from Baseline (Week -2) to end of the treatment (Week 12) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) before and after dialysis was reported. Baseline measure was considered as (Week -2) evaluation for this parameter.
Measured: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Number of Participants With Abnormal Electrocardiogram
Participants with abnormal electrocardiogram were reported.
Measured: At Week -2 and Week 12
Mean Values of White Blood Cells and Platelets Over Time
Mean values of white blood cells (WBCs), and platelets at Weeks -2, 4, 8, and 12 were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Hypochromic Red Blood Cells Over Time
Mean values of hypochromic red blood cells (RBCs) at Weeks -2, 4, 8, and 12 were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Corpuscular Volume Levels Over Time
Mean corpuscular volume (MCV) is a measure of the average red blood cell volume. MCV levels at Weeks -2, 4, 8, and 12 were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Mean values of serum iron and total iron binding capacity (TIBC) were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Serum Ferritin Over Time
Mean values of serum ferritin were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Over Time
Mean values of transferrin were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Saturation Over Time
Mean values of Transferrin Saturation (TSAT) were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Serum Albumin and Serum Globulin Over Time
Mean values of serum albumin and serum globulin were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Mean values of aspartate aminotransferase (AST), alanine transaminase (ALT) and serum alkaline phosphatase were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Mean values of serum creatinine, blood urea nitrogen (BUN), serum phosphate and serum bilirubin were reported.
Measured: At Weeks -2, 4, 8, and 12
Mean Values of Serum Sodium and Serum Potassium Over Time
Mean values of serum sodium and serum potassium were reported.
Measured: At Weeks -2, 4, 8, and 12

Timeline

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

26 Aug 200812 Sep 2009

First posted19 Aug 2008 (estimated)
Study start26 Aug 2008
Primary completion12 Sep 2009
Study completion12 Sep 2009

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: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737464
Sponsor's protocol ID: ML21810
Status last verified: Nov 2017
First submitted: 18 Aug 2008
Last updated: 7 Dec 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

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

All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous MIRCERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia
ClinicalTrials.gov ID: NCT00737464
Acronym / sponsor ID: ML21810
Conditions: Anemia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 26 Aug 2008 (actual)
Primary completion: 12 Sep 2009 (actual)
Study completion: 12 Sep 2009 (actual)
First posted: 19 Aug 2008 (estimated)
Results: Posted 29 Apr 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]Participant with chronic renal anemia will receive methoxy polyethylene glycol-epoetin beta [Mircera] intravenously (IV) [(120, 200 or 360 micrograms (mcg)] every 4 weeks for 12 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

male or female patients, >=18 years of age;
chronic renal anemia;
Hb concentration 10.5g/dL - 12.5g/dL;
continuous intravenous maintenance therapy with epoetin alfa at the same dosing interval during the previous 2 months.

Key exclusion criteria (5 listed)

blood transfusion within the previous 2 months;
poorly controlled hypertension;
significant acute or chronic bleeding;
active malignant disease;
congestive heart failure (NYHA Class IV).

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]iv (120, 200 or 360 micrograms) every 4 weeks for 12 weeks.	Drug	Mircera

Primary outcome

Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)
Time frame: Weeks 8 to 12 (Last 4 weeks of treatment period)
Participants maintaining mean hemoglobin (Hb) concentration within the target range i.e. 10.0 - 12.0 gram per deciliter (g/dL) during last 4 weeks (Weeks 8 to 12) of treatment period (TP) were reported. Total duration for treatment period was 12 weeks. Stability verification period of 2-weeks was conducted before treatment period. The reference Hb concentrations were based upon the mean of the assessments at Weeks -2, -1 and Week 0. The target range for assessment was set at the reference value Hb +/- 1 g/dL but not >12.0 g/dL and not <10.0 g/dL.

17 secondary outcomes

Mean Hemoglobin Concentration Between Stability Verification Period (Weeks -2 to -1) and Treatment Period (Weeks 8 to 12)
Time frame: SVP (Weeks -2 to -1) and TP (Weeks 8 to 12)
Mean Time Participants Spent Having Hemoglobin Range of 10.0 to 12.0 g/dL
Time frame: Up to Week 12
Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Deaths
Time frame: Up to Week 14
Mean Change From Baseline in Heart Rate Over Time
Time frame: From Baseline (Week -1) to Weeks 0, 1, 2, 4, 6, 8, 10, and 12
Mean Change From Baseline in Blood Pressure (Systolic Blood Pressure and Diastolic Blood Pressure) Over Time
Time frame: From Baseline (Week -2) to Weeks -1, 0, 1, 2, 4, 6, 8, 10, and 12
Number of Participants With Abnormal Electrocardiogram
Time frame: At Week -2 and Week 12
Mean Values of White Blood Cells and Platelets Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Hypochromic Red Blood Cells Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Corpuscular Volume Levels Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Iron Parameters (Serum Iron and Total Iron Binding Capacity) Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Ferritin Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Transferrin Saturation Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Albumin and Serum Globulin Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Aspartate Aminotransferase, Alanine Transaminase and Serum Alkaline Phosphatase Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Creatinine, Blood Urea Nitrogen, Serum Phosphate and Serum Bilirubin Over Time
Time frame: At Weeks -2, 4, 8, and 12
Mean Values of Serum Sodium and Serum Potassium Over Time
Time frame: At Weeks -2, 4, 8, and 12

Results and safety

Results posted to the registry on 29 Apr 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	132	114

Primary outcome: Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12)

Time frame: Weeks 8 to 12 (Last 4 weeks of treatment period). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Mircera n = 114
Value	57.89 (48.29 to 67.08)

Population analysed: Per-protocol (PP) population comprised of participants who had received at least 1 dose of MIRCERA (Week 0) and for whom data for at least one follow-up variable was available and who had completed the study.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 14. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mircera	9 of 132 (6.8%)	36 of 132 (27.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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

17 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 17 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 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 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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.

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 29 Apr 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?

Percentage of Participants Maintaining Mean Hemoglobin Levels Within the Target Range During the Last 4 Weeks of the Treatment Period (Weeks 8 to 12) (time frame: Weeks 8 to 12 (Last 4 weeks of treatment period)). 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 NCT00737464.

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 7 Dec 2017.