Clinical trial NCT02238080: An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis
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®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Diseases
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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 (%)

Exclusion Criteria:

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

Primary outcomes:
measure: Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
timeFrame: Day 1
measure: Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
timeFrame: Month 6
measure: Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
timeFrame: Baseline, Month 6
measure: Serum CRP Level
timeFrame: Baseline, Month 6
measure: Serum IL-6 Level
timeFrame: Baseline, Month 6
measure: Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
timeFrame: Month 6
measure: Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6
timeFrame: Month 6
measure: Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
timeFrame: Day 1
measure: Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose
timeFrame: Day 1
measure: Serum Hemoglobin Level
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Hospital; Nephrology
city: Ashkelon
country: Israel
facility: Barzilai Medical Centre ; Nephrology and Hypertension
city: Beer Sheva
country: Israel
facility: Soroka Medical Center; Nephrology
city: Haifa
country: Israel
facility: Bnai Zion MC; Nephrology
city: Haifa
country: Israel
facility: Carmel Medical Center; Nephrology
city: Holon
country: Israel
facility: Wolfson MC; Nephrology
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center; Nrphrology Dept.
city: Jerusalem
country: Israel
facility: Hadassah Medical Orgainastion; Nephrology
city: Kfar Saba
country: Israel
facility: Meir Medical Center; Nephrology Dept.
city: Nahariya
country: Israel
facility: Western Galilee Hospital; Nrphrology Dept.
city: Nazareth
country: Israel
facility: EMMS Nazareth; Nephrology
city: Nazareth
country: Israel
facility: Holy Family Hospital; Nephrology
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center; Nephrology
city: Ramat-Gan
country: Israel
facility: Sheba MC; Nephrology
city: Safed
country: Israel
facility: Rebecca Sief Hospital; Nephrology
city: Tel Aviv
country: Israel
facility: Sourasky MC; Dept. of Nephrology
city: Tiberias
country: Israel
facility: Poria Hospital; Nephrology
city: Zrifin
country: Israel
facility: Assaf-Harofeh MC; Nephrology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: