Chronic Kidney DiseasesIMPACTNCT02238080

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

An observational study of Chronic Kidney Diseases, run by Hoffmann-La Roche at 18 sites in Israel.

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: Chronic Kidney Diseases
What is being tested?: Methoxy Polyethylene Glycol-Epoetin Beta
How many people: 197 participants
Where: 18 sitesIsrael
Study dates: Dec 2009to Jun 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: Adult participants with CKD on dialysis therapy, either initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or on stable methoxy polyethylene glycol-epoetin beta maintenance therapy. The study is to be conducted in Israel.

Who may be able to join

CKD participants undergoing dialysis
Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Who cannot join

Conditions known to cause inadequate response to ESA treatment
Anemia other than symptomatic anemia associated with CKD

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Israel18 sites

Haemek Hospital; Nephrology
Afula, 18101
Barzilai Medical Centre ; Nephrology and Hypertension
Ashkelon, 78306
Soroka Medical Center; Nephrology
Beersheba, 84101
Bnai Zion MC; Nephrology
Haifa, 31048
Carmel Medical Center; Nephrology
Haifa, 34362
Wolfson MC; Nephrology
Holon, 58100
Shaare Zedek Medical Center; Nrphrology Dept.
Jerusalem, 91031
Hadassah Medical Orgainastion; Nephrology
Jerusalem, 91120
Meir Medical Center; Nephrology Dept.
Kfar Saba, 44281
Western Galilee Hospital; Nrphrology Dept.
Nahariya, 22100
EMMS Nazareth; Nephrology
Nazareth, 16100
Holy Family Hospital; Nephrology
Nazareth, 16100
Beilinson Medical Center; Nephrology
Petah Tikva, 49100
Sheba MC; Nephrology
Ramat Gan, 52621
Rebecca Sief Hospital; Nephrology
Safed, 13100
Sourasky MC; Dept. of Nephrology
Tel Aviv, 6423906
Poria Hospital; Nephrology
Tiberias
Assaf-Harofeh MC; Nephrology
Zrifin, 70300

Other trials in Israel

About this study

Official title: Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®

This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

Conditions: Chronic Kidney Diseases
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®
Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.

Study groups in NCT02238080
Study group	Role	What they receive
Methoxy Polyethylene Glycol-Epoetin Beta		Participants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period. Receives: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

What is being measured

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

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Measured: Day 1
Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Measured: Day 1

Secondary outcomes (9)

Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).
Measured: Month 6
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Measured: Baseline, Month 6
Serum CRP Level
Measured: Baseline, Month 6
Serum IL-6 Level
Measured: Baseline, Month 6
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Measured: Month 6
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Measured: Month 6
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Measured: Day 1
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Measured: Day 1
Serum Hemoglobin Level
Measured: Baseline, Month 6

Timeline

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

Dec 2009Jun 2012

First posted12 Sep 2014 (estimated)
Study startDec 2009
Primary completionJun 2012
Study completionJun 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 Chronic Kidney DiseasesStudies 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: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02238080
Sponsor's protocol ID: ML22556
Acronym: IMPACT
Status last verified: Apr 2017
First submitted: 10 Sep 2014
Last updated: 15 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

All Chronic Kidney Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®
ClinicalTrials.gov ID: NCT02238080
Acronym / sponsor ID: IMPACT / ML22556
Conditions: Chronic Kidney Diseases
Study type: Observational
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 12 Sep 2014 (estimated)
Results: Posted 6 Apr 2017

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
Methoxy Polyethylene Glycol-Epoetin Beta	–	Drug: Methoxy Polyethylene Glycol-Epoetin BetaParticipants with anemia and CKD who are on dialysis therapy, and who initiate erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta or who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, will be treated according to the usual standard of care and current best practice guidelines, and will be observed during the study period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult participants with CKD on dialysis therapy, either initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or on stable methoxy polyethylene glycol-epoetin beta maintenance therapy. The study is to be conducted in Israel.

Key inclusion criteria (3 listed)

CKD participants undergoing dialysis
Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Key exclusion criteria (2 listed)

Conditions known to cause inadequate response to ESA treatment
Anemia other than symptomatic anemia associated with CKD

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®Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.	Drug	Methoxy Polyethylene Glycol-Epoetin Beta

Primary outcome

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time frame: Day 1
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time frame: Day 1
Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

9 secondary outcomes

Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time frame: Month 6
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time frame: Baseline, Month 6
Serum CRP Level
Time frame: Baseline, Month 6
Serum IL-6 Level
Time frame: Baseline, Month 6
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time frame: Month 6
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
Time frame: Month 6
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time frame: Day 1
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
Time frame: Day 1
Serum Hemoglobin Level
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 6 Apr 2017, 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	197	172

Primary outcome: Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Time frame: Day 1. Number. Unit: correlation coefficient

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 185
Value	0.1485

Population analysed: ITT population. Participants with stable maintenance treatment were included in this analysis. 'Number of participants analyzed' (N) included participants evaluable for this outcome measure.

Primary outcome: Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

Time frame: Day 1. Number. Unit: correlation coefficient

Measure	Methoxy Polyethylene Glycol-Epoetin Beta n = 185
Value	0.05557

9 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Methoxy Polyethylene Glycol-Epoetin Beta	48 of 197 (24.4%)	15 of 197 (7.6%)	Not reported

Limitations and caveats (from the sponsor): The study was completed as defined in the protocol. Only 197 participants (out of planned 400) were enrolled due to slow recruitment during the study period.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Diseases

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
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases

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

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Diseases, run by Hoffmann-La Roche at 18 sites in Israel.

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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Israel. 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 6 Apr 2017). 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?

Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose (time frame: Day 1). The study lists 2 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 NCT02238080.

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 15 May 2017.