AnemiaNCT01940484

An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

An observational study of Anemia, run by Hoffmann-La Roche at 10 sites in South Africa.

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
How many people: 98 participants
Where: 10 sitesSouth Africa
Study dates: 31 Aug 2009to 31 Jul 2012
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 Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).

Who may be able to join

Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
Participants had to be receiving an ESA prior to entering the study
Female participants of childbearing age had to be using effective contraceptive methods

Who cannot join

As per approved package insert
Any contraindication to ESA treatment

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

South Africa10 sites

Glynnwood Hospital
Benoni, 1501
Universitas Private Hospital
Bloemfontein, 9301
GVI Constantiaberg
Cape Town, 7800
Groote Schuur Hospital; Renal Unit
Cape Town, 7925
N1City Hospital
Cape Town, 7925
Dr KB Parag & Raghubir Kidney and Dialysis Centre
Durban, 4001
St Augustine Hospital / Chelmsford Medical Center; Nephrology
Durban
Mayo Clinic
Johannesburg, 1724
Sunninghill Hospital
Johannesburg, 2157
Donald Gordon Medical Centre
Johannesburg, 2193

Other trials in South Africa

About this study

Official title: An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

Conditions: Anemia
Being tested: Methoxy polyethylene glycol epoetin beta
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 betaDrug
Also called Mircera

Study groups in NCT01940484
Study group	Role	What they receive
Chronic Renal Anemia Participants		Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months. Receives: Drug: Methoxy polyethylene glycol epoetin beta

What is being measured

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

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
Measured: Visit 2 (Month 1)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
Measured: Visit 3 (Month 2)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
Measured: Visit 4 (Month 3)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
Measured: Visit 5 (Month 4)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
Measured: Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
Measured: Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 2 (Month 1)
Measured: Visit 2 (Month 1)
Mean Hemoglobin Value at Visit 3 (Month 2)
Measured: Visit 3 (Month 2)
Mean Hemoglobin Value at Visit 4 (Month 3)
Measured: Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 5 (Month 4)
Measured: Visit 5 (Month 4)
Mean Hemoglobin Value at Visit 6 (Month 5)
Measured: Visit 6 (Month 5)
Mean Hemoglobin Value at Visit 7 (Month 6)
Measured: Visit 7 (Month 6)

Secondary outcomes (3)

Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Measured: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.
Measured: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)
Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert
Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.
Measured: Up to 6 months

Timeline

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

31 Aug 200931 Jul 2012

First posted12 Sep 2013 (estimated)
Study start31 Aug 2009
Primary completion31 Jul 2012
Study completion31 Jul 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01940484
Sponsor's protocol ID: ML22344
Status last verified: May 2017
First submitted: 9 Sep 2013
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

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 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis
ClinicalTrials.gov ID: NCT01940484
Acronym / sponsor ID: ML22344
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Aug 2009 (actual)
Primary completion: 31 Jul 2012 (actual)
Study completion: 31 Jul 2012 (actual)
First posted: 12 Sep 2013 (estimated)
Results: Posted 20 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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic Renal Anemia Participants	–	Drug: Methoxy polyethylene glycol epoetin betaParticipants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).

Key inclusion criteria (3 listed)

Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
Participants had to be receiving an ESA prior to entering the study
Female participants of childbearing age had to be using effective contraceptive methods

Key exclusion criteria (2 listed)

As per approved package insert
Any contraindication to ESA treatment

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 betaAlso: Mircera	Drug	Chronic Renal Anemia Participants

Primary outcome

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)
Time frame: Visit 2 (Month 1)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)
Time frame: Visit 3 (Month 2)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)
Time frame: Visit 4 (Month 3)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)
Time frame: Visit 5 (Month 4)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)
Time frame: Visit 6 (Month 5)
Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)
Time frame: Visit 7 (Month 6)
Mean Hemoglobin Value at Visit 2 (Month 1)
Time frame: Visit 2 (Month 1)
Mean Hemoglobin Value at Visit 3 (Month 2)
Time frame: Visit 3 (Month 2)
Mean Hemoglobin Value at Visit 4 (Month 3)
Time frame: Visit 4 (Month 3)
Mean Hemoglobin Value at Visit 5 (Month 4)
Time frame: Visit 5 (Month 4)
Mean Hemoglobin Value at Visit 6 (Month 5)
Time frame: Visit 6 (Month 5)
Mean Hemoglobin Value at Visit 7 (Month 6)
Time frame: Visit 7 (Month 6)

3 secondary outcomes

Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study
Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)
Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta
Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)
Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 20 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
Chronic Renal Anemia Participants	98	88

Primary outcome: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)

Time frame: Visit 2 (Month 1). Number. Unit: participants

Measure	Chronic Renal Anemia Participants n = 87
Value	23

Population analysed: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.

Primary outcome: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)

Time frame: Visit 3 (Month 2). Number. Unit: participants

Measure	Chronic Renal Anemia Participants n = 89
Value	26

Population analysed: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.

Primary outcome: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)

Time frame: Visit 4 (Month 3). Number. Unit: participants

Measure	Chronic Renal Anemia Participants n = 86
Value	22

Population analysed: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.

Primary outcome: Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)

Time frame: Visit 5 (Month 4). Number. Unit: participants

Measure	Chronic Renal Anemia Participants n = 83
Value	17

Population analysed: Included all enrolled participants who were evaluable for this outcome at the specified timepoint.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Renal Anemia Participants	79 of 98 (80.6%)	0 of 0	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

10 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 10 sites in South Africa.

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 3 inclusion and 2 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 10 sites in South Africa. 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 20 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?

Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1) (time frame: Visit 2 (Month 1)). The study lists 12 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 NCT01940484.

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.