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

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: Methoxy Polyethylene Glycol-Epoetin Beta

• Registration Number: NCT02238080
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Results First Submitted: 2017-02-20
• Results First Submitted QC: 2017-02-20
• Status Verified: 2017-04
• Results First Posted: 2017-04-06
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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 (%)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Methoxy Polyethylene Glycol-Epoetin Beta	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum Hemoglobin Level	Baseline, Month 6
Serum CRP Level	Baseline, Month 6
Serum IL-6 Level	Baseline, Month 6
Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose	Day 1
Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose	Day 1
Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6	Month 6	Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).
Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6	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).
Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6	Baseline, Month 6
Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6	Month 6	Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Trial Locations

Locations (18)

Holy Family Hospital; Nephrology; 🇮🇱 Nazareth, Israel

Rebecca Sief Hospital; Nephrology; 🇮🇱 Safed, Israel

Sourasky MC; Dept. of Nephrology; 🇮🇱 Tel Aviv, Israel

Soroka Medical Center; Nephrology; 🇮🇱 Beer Sheva, Israel

Bnai Zion MC; Nephrology; 🇮🇱 Haifa, Israel

Haemek Hospital; Nephrology; 🇮🇱 Afula, Israel

Western Galilee Hospital; Nrphrology Dept.; 🇮🇱 Nahariya, Israel

EMMS Nazareth; Nephrology; 🇮🇱 Nazareth, Israel

Assaf-Harofeh MC; Nephrology; 🇮🇱 Zrifin, Israel

Barzilai Medical Centre ; Nephrology and Hypertension; 🇮🇱 Ashkelon, Israel

Wolfson MC; Nephrology; 🇮🇱 Holon, Israel

Beilinson Medical Center; Nephrology; 🇮🇱 Petach Tikva, Israel

Poria Hospital; Nephrology; 🇮🇱 Tiberias, Israel

Carmel Medical Center; Nephrology; 🇮🇱 Haifa, Israel

Hadassah Medical Orgainastion; Nephrology; 🇮🇱 Jerusalem, Israel

Shaare Zedek Medical Center; Nrphrology Dept.; 🇮🇱 Jerusalem, Israel

Meir Medical Center; Nephrology Dept.; 🇮🇱 Kfar Saba, Israel

Sheba MC; Nephrology; 🇮🇱 Ramat-Gan, Israel