Kidney Disease, ChronicNCT01318512

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

An observational study of Kidney Disease, Chronic, run by Hoffmann-La Roche at 1 site in Czechia.

Completed

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

Trial summary

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Disease, Chronic
Type of treatment: Injection or infusion
How many people: 340 participants
Where: 1 siteCzechia
Study dates: 31 Jul 2010to 31 Dec 2013
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 receiving Mircera treatment

Who may be able to join

Adults patients, >/=18 years of age
Presence of chronic kidney disease (Stage 3-4)

Who cannot join

Participation in another clinical study

Trial locations and contacts

1 site in 1 country.

Czechia1 site

Nemocnice Novy Jicin; Dialyzacni Stredisko
Nový Jičín, 741 11

Other trials in Czechia

About this study

Official title: The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

Conditions: Kidney Disease, Chronic
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

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

Study groups in NCT01318512
Study group	Role	What they receive
Chronic Kidney Disease		Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.

What is being measured

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

Average Dose of MIRCERA at Entry Level
The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Measured: Baseline
Average Dose of MIRCERA During Titration Period Month 1
The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Measured: Month 1
Average Dose of MIRCERA During Titration Period Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Measured: Month 2
Average Dose of MIRCERA During Titration Period Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Measured: Month 3
Average Dose of MIRCERA During Titration Period Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Measured: Month 4
Average Dose of MIRCERA During Maintenance Period Month 1
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 5 (Maintenance Period Month 1)
Average Dose of MIRCERA During Maintenance Period Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 6 (Maintenance Period Month 2)
Average Dose of MIRCERA During Maintenance Period Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 7 (Maintenance Period Month 3)
Average Dose of MIRCERA During Maintenance Period Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 8 (Maintenance Period Month 4)
Average Dose of MIRCERA During Maintenance Period Month 5
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 9 (Maintenance Period Month 5)
Average Dose of MIRCERA During Maintenance Period Month 6
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Measured: Month 10 (Maintenance Period Month 6)

Secondary outcomes (2)

The Mean Hemoglobin (Hb) Level During Titration Period
The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.
Measured: Baseline, Month 1, 2, 3, 4
The Mean Hemoglobin (Hb) Level During Maintenance Period
The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA
Measured: Month 5, 6, 7, 8, 9, 10

Timeline

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

31 Jul 201031 Dec 2013

First posted18 Mar 2011 (estimated)
Study start31 Jul 2010
Primary completion31 Dec 2013
Study completion31 Dec 2013

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 Kidney Disease, ChronicStudies 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: 340 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318512
Sponsor's protocol ID: ML25317
Status last verified: May 2017
First submitted: 17 Mar 2011
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

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All Kidney Disease, Chronic 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: The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice
ClinicalTrials.gov ID: NCT01318512
Acronym / sponsor ID: ML25317
Conditions: Kidney Disease, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 340 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Jul 2010 (actual)
Primary completion: 31 Dec 2013 (actual)
Study completion: 31 Dec 2013 (actual)
First posted: 18 Mar 2011 (estimated)
Results: Posted 3 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
Chronic Kidney Disease	–	–Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.

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 receiving Mircera treatment

Key inclusion criteria (2 listed)

Adults patients, >/=18 years of age
Presence of chronic kidney disease (Stage 3-4)

Key exclusion criteria (1 listed)

Participation in another clinical study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Average Dose of MIRCERA at Entry Level
Time frame: Baseline
The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Average Dose of MIRCERA During Titration Period Month 1
Time frame: Month 1
The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 2
Time frame: Month 2
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 3
Time frame: Month 3
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 4
Time frame: Month 4
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Maintenance Period Month 1
Time frame: Month 5 (Maintenance Period Month 1)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 2
Time frame: Month 6 (Maintenance Period Month 2)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 3
Time frame: Month 7 (Maintenance Period Month 3)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 4
Time frame: Month 8 (Maintenance Period Month 4)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 5
Time frame: Month 9 (Maintenance Period Month 5)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 6
Time frame: Month 10 (Maintenance Period Month 6)
The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

2 secondary outcomes

The Mean Hemoglobin (Hb) Level During Titration Period
Time frame: Baseline, Month 1, 2, 3, 4
The Mean Hemoglobin (Hb) Level During Maintenance Period
Time frame: Month 5, 6, 7, 8, 9, 10

Results and safety

Results posted to the registry on 3 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
Chronic Kidney Disease (CKD)	340	340

Primary outcome: Average Dose of MIRCERA at Entry Level

Time frame: Baseline. Mean (Standard Deviation). Unit: microgram (µg)

Measure	Chronic Kidney Disease (CKD) n = 340
Value	94 (49)

Population analysed: All participants who received at least one dose of MIRCERA during the titration period.

Primary outcome: Average Dose of MIRCERA During Titration Period Month 1

Time frame: Month 1. Mean (Standard Deviation). Unit: microgram (µg)

Measure	Chronic Kidney Disease (CKD) n = 340
Value	101.3 (54)

Population analysed: All participants who received at least one dose of MIRCERA during titration period.

Primary outcome: Average Dose of MIRCERA During Titration Period Month 2

Time frame: Month 2. Mean (Standard Deviation). Unit: microgram (µg)

Measure	Chronic Kidney Disease (CKD) n = 340
Value	102.4 (54.3)

Population analysed: All participants who received at least one dose of MIRCERA during titration period.

Primary outcome: Average Dose of MIRCERA During Titration Period Month 3

Time frame: Month 3. Mean (Standard Deviation). Unit: microgram (µg)

Measure	Chronic Kidney Disease (CKD) n = 340
Value	106.1 (56.2)

Population analysed: All participants who received at least one dose of MIRCERA during titration period.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3.5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chronic Kidney Disease (CKD)	5 of 340 (1.5%)	2 of 340 (0.6%)	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 Kidney Disease, Chronic

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Disease, Chronic, run by Hoffmann-La Roche at 1 site in Czechia.

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 2 inclusion and 1 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 1 site in Czechia. 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 3 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?

Average Dose of MIRCERA at Entry Level (time frame: Baseline). The study lists 11 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 NCT01318512.

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.