AnemiaNCT01417377

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Anemic Patients With Chronic Kidney Disease (NORM)

An observational study of Anemia, run by Hoffmann-La Roche at 6 sites in Pakistan.

Completed

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

Trial summary

This observational, prospective, multi-centre, single-arm study will evaluate the efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease previously on treatment with short-acting epoetin alpha. Data will be collected for 6 months. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia
What is being tested?: Mircera
How many people: 22 participants
Where: 6 sitesPakistan
Study dates: 31 May 2010to 31 Mar 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: Patients with chronic kidney disease

Who may be able to join

Adult patients, age 18 years or above
Chronic kidney disease (CKD) with anemia
Patients on dialysis receiving short-acting epoetin (EPO)
Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%

Who cannot join

Patients unwilling to give informed consent
Uncontrolled hypertension
Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
Relevant acute or chronic bleeding history
Hemolysis
Hemoglobinopathies
Pure red cell aplasia

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Pakistan6 sites

Sheikh Zayed Hospital; Department of Nephrology
Lahore, 20021
Fatima Memorial Hospital; Nephrology
Lahore, 54590
Doctor's Hospital and Medical Centre
Lahore
Khair-un-Nisa Hospital
Lahore
Surgimed Hospital
Lahore
Northwest General Hospital; Department of Nephrology
Peshawar

Other trials in Pakistan

About this study

Official title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)

Conditions: Anemia
Being tested: Mircera
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MirceraDrug
Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.

Study groups in NCT01417377
Study group	Role	What they receive
Cohort		Mircera Receives: Drug: Mircera

What is being measured

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

Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
Measured: Month 4 up to Month 6

Secondary outcomes (3)

Time to Achieve Hb Level to 11-12 g/dL
Measured: Up to 6 months
Number of Dose Adjustments Required to Maintain Hb Levels
Measured: Up to 6 months
Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)
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 May 201031 Mar 2012

First posted16 Aug 2011 (estimated)
Study start31 May 2010
Primary completion31 Mar 2012
Study completion31 Mar 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01417377
Sponsor's protocol ID: ML25368
Status last verified: May 2017
First submitted: 5 Aug 2011
Last updated: 13 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

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All Anemia trials

Study at a glance

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

Official title: Non-Interventional Study to Document the Efficacy in Routine Clinical Practice of Mircera in Pakistan (NORM)
ClinicalTrials.gov ID: NCT01417377
Acronym / sponsor ID: ML25368
Conditions: Anemia
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 May 2010 (actual)
Primary completion: 31 Mar 2012 (actual)
Study completion: 31 Mar 2012 (actual)
First posted: 16 Aug 2011 (estimated)
Results: Posted 9 Dec 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

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

Arm	Type	Receives
Cohort	–	Drug: MirceraMircera

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with chronic kidney disease

Key inclusion criteria (4 listed)

Adult patients, age 18 years or above
Chronic kidney disease (CKD) with anemia
Patients on dialysis receiving short-acting epoetin (EPO)
Serum ferritin level >/=100 ng/ml or transferrin saturation (TSAT) >/=20%

Key exclusion criteria (7 listed)

Patients unwilling to give informed consent
Uncontrolled hypertension
Transfusion of red blood cells within 8 weeks of the start of Mircera treatment
Relevant acute or chronic bleeding history
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
MirceraParticipants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.	Drug	Cohort

Primary outcome

Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study
Time frame: Month 4 up to Month 6

3 secondary outcomes

Time to Achieve Hb Level to 11-12 g/dL
Time frame: Up to 6 months
Number of Dose Adjustments Required to Maintain Hb Levels
Time frame: Up to 6 months
Number of Doses of Mircera Taken as Per the Schedule in Summary of Product Characteristics (SmPC)
Time frame: Up to 6 months

Results and safety

Results posted to the registry on 9 Dec 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
Mircera	22	9

Primary outcome: Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study

Time frame: Month 4 up to Month 6

Population analysed: None of the enrolled participants in the study achieved Hb level between 11 to 12 g/dL during the final 2 months of study, therefore this particular endpoint was not analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mircera	3 of 22 (13.6%)	11 of 22 (50%)	Not reported

Limitations and caveats (from the sponsor): As none of the enrolled participants in the study achieved the endpoint of maintaining Hb level between 11-12 g/dL during the final 2 months of study, therefore efficacy parameters were not analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 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

6 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 6 sites in Pakistan.

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 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: finished, as of the sponsor's last update on 13 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 6 sites in Pakistan. 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 9 Dec 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?

Percentage of Participants Maintaining Hemoglobin (Hb) Levels Between 11-12 Gram Per Deciliter (g/dL) During Final 2 Months of Study (time frame: Month 4 up to Month 6). 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 NCT01417377.

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 Jul 2017.