Kidney Disease, ChronicNCT02547454

An Observational Study to Evaluate the Effectiveness of Mircera Treatment for Renal Anemia in Pre-dialysis Participants With Chronic Kideny Disease (CKD)

An observational study of Kidney Disease, Chronic, run by Hoffmann-La Roche at 12 sites in Slovenia.

Completed

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

Trial summary

This observational trial will examine the efficacy and safety of Mircera for renal anemia in participants with stage III-IV CKD in daily clinical practice. Mircera will be prescribed by treating physician and followed for approximately 36 months. Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Kidney Disease, Chronic
What is being tested?: Methoxy polyethylene glycol-epoetin beta
How many people: 393 participants
Where: 12 sitesSlovenia
Study dates: 31 Dec 2008to 30 Nov 2014
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with CKD who do not require dialysis and are appropriate for treatment with Mircera according to European Best Practice Guidelines (EBPG) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.

Who may be able to join

Participants aged > 18 years with CKD
Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Who cannot join

Non-renal anemia
Pregnancy and breast-feeding
Uncontrolled hypertension
Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
Administration of any other study drug within 30 days prior to study enrollment

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Slovenia12 sites

Hospital Celje; Dept For Kidney Disease & Dialysis
Celje, 3000
Splosna Bolnisnica Izola; Oddelek Za Nefrologijo
Izola, 6310
Clinical Centre Ljubljana; Clinical Dep. For Nephrology
Ljubljana, 1000
Nefroloska Ambulanta
Ljubljana, 1000
Hospital Maribor; Clinical Dept For Internal Medicine
Maribor, 2000
Splosna Bolnisnica Murska Sobota; Oddelek Za Nefrologijo
Murska Sobota, 9000
Zdravstveni Zavod Medicinski Center Šinigoj Nova Gorica
Nova Gorica, 5000
Hospital Novo Mesto; Dialysis Dept
Novo Mesto, 8000
Hospital Dr.Joze Potre; Dialysis Dept
Ptuj, 2250
Splosna Bolnisnica Franc Derganc; Oddelek Za Nefrologijo
Sempeter Pri Novi Gorici, 5390
Hospital Slovenj Gradec; Hemodialysis Dept
Slovenj Gradec, 2380
Splosna Bolnisnica Trbovlje; Oddelek Za Nefrologijo
Trbovlje, 1420

Other trials in Slovenia

About this study

Official title: Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA

Conditions: Kidney Disease, Chronic
Being tested: Methoxy polyethylene glycol-epoetin beta
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.

Methoxy polyethylene glycol-epoetin betaDrug
Also called Mircera

Study groups in NCT02547454
Study group	Role	What they receive
CKD participants treated with Mircera		Participants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 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.

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: Baseline
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: After 21 Months up to 36 Months
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Baseline
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 1-3
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 4-6
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 7-9
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 10-12
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 13-15
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 16-18
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: At Months 19-21
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Measured: After 21 Months up to 36 Months

Secondary outcomes (7)

Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
Measured: Up to 36 Months
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
Measured: Up to 36 Months
Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Average dose of methoxy polyethylene glycol-epoetin beta administered at Baseline
Measured: Baseline
Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Median monthly dose of methoxy polyethylene glycol-epoetin beta administered in the study up to 36 months.
Measured: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Number of Dose Adaptations
Total number of changes (increase or decrease) in daily methoxy polyethylene glycol-epoetin beta doses. The reasons for dose-adaptations included: inflammation or infection; kidney function decline; over-response; iron deficiency; insufficient response; adverse effect; start of maintenance dose; kidney function improvement; re-introduction of treatment; and others (other reasons than specified).
Measured: Up to 36 Months
Percentage of Participants With Dose 0
Percentage of participants who did not use methoxy polyethylene glycol-epoetin beta (Dose 0) at atleast one visit during study period.
Measured: Up to 36 Months
Percentage of Participants With Iron Replacement
Iron replacement was given to the participants either in oral iron replacement or intravenous replacement or both.
Measured: Up to 36 Months

Timeline

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

31 Dec 200830 Nov 2014

First posted11 Sep 2015 (estimated)
Study start31 Dec 2008
Primary completion30 Nov 2014
Study completion30 Nov 2014

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: Case only
Time perspective: Prospective
Enrolment: 393 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02547454
Sponsor's protocol ID: ML22069
Status last verified: May 2017
First submitted: 9 Sep 2015
Last updated: 7 Jun 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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Study at a glance

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

Official title: Investigating the Effectiveness of Renal Anaemia Treatment in Pre-Dialysis Patients With Mircera in Daily Clinical Practice - MIRVITA
ClinicalTrials.gov ID: NCT02547454
Acronym / sponsor ID: ML22069
Conditions: Kidney Disease, Chronic
Study type: Observational
Recruitment status: Completed
Enrolment: 393 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Dec 2008 (actual)
Primary completion: 30 Nov 2014 (actual)
Study completion: 30 Nov 2014 (actual)
First posted: 11 Sep 2015 (estimated)
Results: Posted 23 Nov 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: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
CKD participants treated with Mircera	–	Drug: Methoxy polyethylene glycol-epoetin betaParticipants with CKD received Mircera, as per routine clinical practice and was followed for approximately 36 months.

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with CKD who do not require dialysis and are appropriate for treatment with Mircera according to European Best Practice Guidelines (EBPG) and Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines.

Key inclusion criteria (2 listed)

Participants aged > 18 years with CKD
Participants who are eligible for Mircera treatment according to current guidelines and summary of product characteristics (SmPC)

Key exclusion criteria (5 listed)

Non-renal anemia
Pregnancy and breast-feeding
Uncontrolled hypertension
Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
Administration of any other study drug within 30 days prior to study enrollment

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	CKD participants treated with Mircera

Primary outcome

Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline
Time frame: Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3
Time frame: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6
Time frame: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9
Time frame: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 10-12
Time frame: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 13-15
Time frame: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 16-18
Time frame: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 19-21
Time frame: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) After 21 Months up to 36 Months
Time frame: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (100 to 130 g/L) at Baseline
Time frame: At Baseline
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 1-3
Time frame: At Months 1-3
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 4-6
Time frame: At Months 4-6
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 7-9
Time frame: At Months 7-9
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 10-12
Time frame: At Months 10-12
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 13-15
Time frame: At Months 13-15
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 16-18
Time frame: At Months 16-18
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) at Months 19-21
Time frame: At Months 19-21
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.
Percentage of Participants With Hb Value Within the Target Range (100 to 130 g/L) After 21 Months up to 36 Months
Time frame: After 21 Months up to 36 Months
If a participant had more than 1 assessment during the specified time frame, the last observed Hb value was considered for calculation.

7 secondary outcomes

Median Time in Which Hb Value Was Maintained Within Target Range of 110-120 g/L
Time frame: Up to 36 Months
Median Time in Which Hb Value Was Maintained Within Target Range of 100-130 g/L
Time frame: Up to 36 Months
Average Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Time frame: Baseline
Median Dose of Methoxy Polyethylene Glycol-Epoetin Beta
Time frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and After 21 Months up to 36 Months
Number of Dose Adaptations
Time frame: Up to 36 Months
Percentage of Participants With Dose 0
Time frame: Up to 36 Months
Percentage of Participants With Iron Replacement
Time frame: Up to 36 Months

Results and safety

Results posted to the registry on 23 Nov 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
Methoxy Polyethylene Glycol-Epoetin Beta	393	221

Primary outcome: Percentage of Participants With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline

Time frame: Baseline. Number. Unit: Percentage of participants

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 390
Value	22.8

Population analysed: Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.

Primary outcome: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 1-3

Time frame: At Months 1-3. Number. Unit: Percentage of participants

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 259
Value	34

Population analysed: Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.

Primary outcome: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 4-6

Time frame: At Months 4-6. Number. Unit: Percentage of participants

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 296
Value	35.1

Population analysed: Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.

Primary outcome: Percentage of Participants With Hb Value Within the Target Range (110 to 120 g/L) at Months 7-9

Time frame: At Months 7-9. Number. Unit: Percentage of participants

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 232
Value	32.3

Population analysed: Analysis population included all enrolled participants who had at least one Hb assessment at the specified time frame.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 36 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-Epoetin Beta	3 of 393 (0.8%)	2 of 393 (0.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

An observational study of Kidney Disease, Chronic, run by Hoffmann-La Roche at 12 sites in Slovenia.

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 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 Jun 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 Slovenia. 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 23 Nov 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 With Hemoglobin (Hb) Value Within the Target Range (110 to 120 Grams Per Liter [g/L]) at Baseline (time frame: Baseline). The study lists 18 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 NCT02547454.

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 Jun 2017.