Renal ImpairmentNCT02596945

Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis

An observational study of Renal Impairment and Renal Anemia of Chronic Kidney Disease, run by Hoffmann-La Roche at 1 site in Germany.

Completed

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

Official record

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Trial summary

This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Impairment, Renal Anemia of Chronic Kidney Disease
What is being tested?: Methoxy polyethylene glycol epoetin beta
How many people: 223 participants
Where: 1 siteGermany
Study dates: 31 Jul 2009to 28 Feb 2011
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 on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor

Who may be able to join

Participants on peritoneal dialysis
Need for Erythropoiesis Stimulating Agent (ESA) therapy
Prescription of methoxy polyethylene glycol epoetin beta by the doctor

Who cannot join

Trial locations and contacts

1 site in 1 country.

Germany1 site

Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Mettmann, 40822

Other trials in Germany

About this study

Official title: Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use

Conditions: Renal Impairment, Renal Anemia of Chronic Kidney Disease
Being tested: Methoxy polyethylene glycol epoetin beta
Medical subject headings: Renal Insufficiency

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
Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).

Study groups in NCT02596945
Study group	Role	What they receive
Peritoneal Dialysis participants		Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 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 Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Measured: Month 7 to Month 9

Secondary outcomes (2)

Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Measured: Month 7 to Month 9
Average Duration in Days Mircera Was Administered at a Stable Dose
Measured: Up to 9 months

Timeline

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

31 Jul 200928 Feb 2011

First posted4 Nov 2015 (estimated)
Study start31 Jul 2009
Primary completion28 Feb 2011
Study completion28 Feb 2011

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 Renal ImpairmentStudies 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: 223 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02596945
Sponsor's protocol ID: ML22000
Status last verified: May 2017
First submitted: 3 Nov 2015
Last updated: 2 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 Renal Impairment trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use
ClinicalTrials.gov ID: NCT02596945
Acronym / sponsor ID: ML22000
Conditions: Renal Impairment, Renal Anemia of Chronic Kidney Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 223 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 31 Jul 2009 (actual)
Primary completion: 28 Feb 2011 (actual)
Study completion: 28 Feb 2011 (actual)
First posted: 4 Nov 2015 (estimated)
Results: Posted 13 Jan 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
Peritoneal Dialysis participants	–	Drug: Methoxy polyethylene glycol epoetin betaParticipants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor

Key inclusion criteria (3 listed)

Participants on peritoneal dialysis
Need for Erythropoiesis Stimulating Agent (ESA) therapy
Prescription of methoxy polyethylene glycol epoetin beta by the doctor

Key exclusion criteria (1 listed)

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: MirceraMethoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).	Drug	Peritoneal Dialysis participants

Primary outcome

Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: Month 7 to Month 9

2 secondary outcomes

Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)
Time frame: Month 7 to Month 9
Average Duration in Days Mircera Was Administered at a Stable Dose
Time frame: Up to 9 months

Results and safety

Results posted to the registry on 13 Jan 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
Peritoneal Dialysis Participants	223	167

Primary outcome: Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9)

Time frame: Month 7 to Month 9. Number. Unit: percentage of participants

Measure	Peritoneal Dialysis Participants n = 162
Value	14.8

Population analysed: Modified Efficacy Set (MES) population (All participants who received at least 1 dose of study drug and for whom at least 2 hemoglobin measurements were available during the evaluation period (Month 7 to Month 9).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 20 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Peritoneal Dialysis Participants	0 of 220 (0%)	0 of 220 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Renal Impairment

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
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
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

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 Renal Impairment and Renal Anemia of Chronic Kidney Disease, run by Hoffmann-La Roche at 1 site in Germany.

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 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 2 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 Germany. 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 13 Jan 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 With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) (time frame: Month 7 to Month 9). 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 NCT02596945.

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 2 Jul 2017.