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

NCT02238080 | Completed Results

• 1 other identifier: ML22556
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 18

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Day 1

Secondary Outcomes (9)

• Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

  Month 6

• Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

  Baseline, Month 6

• Serum CRP Level

  Baseline, Month 6

• Serum IL-6 Level

  Baseline, Month 6

• Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

  Month 6

Study Arms (1)

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.

Drug: Methoxy Polyethylene Glycol-Epoetin Beta

Interventions

Methoxy Polyethylene Glycol-Epoetin Beta DRUG

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.

Also known as: Mircera®

Methoxy Polyethylene Glycol-Epoetin Beta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 (%)

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (18)

Haemek Hospital; Nephrology

Afula, 18101, Israel

Location

Barzilai Medical Centre ; Nephrology and Hypertension

Ashkelon, 78306, Israel

Location

Soroka Medical Center; Nephrology

Beersheba, 84101, Israel

Location

Bnai Zion MC; Nephrology

Haifa, 31048, Israel

Location

Carmel Medical Center; Nephrology

Haifa, 34362, Israel

Location

Wolfson MC; Nephrology

Holon, 58100, Israel

Location

Shaare Zedek Medical Center; Nrphrology Dept.

Jerusalem, 91031, Israel

Location

Hadassah Medical Orgainastion; Nephrology

Jerusalem, 91120, Israel

Location

Meir Medical Center; Nephrology Dept.

Kfar Saba, 44281, Israel

Location

Western Galilee Hospital; Nrphrology Dept.

Nahariya, 22100, Israel

Location

EMMS Nazareth; Nephrology

Nazareth, 16100, Israel

Location

Holy Family Hospital; Nephrology

Nazareth, 16100, Israel

Location

Beilinson Medical Center; Nephrology

Petah Tikva, 49100, Israel

Location

Sheba MC; Nephrology

Ramat Gan, 52621, Israel

Location

Rebecca Sief Hospital; Nephrology

Safed, 13100, Israel

Location

Sourasky MC; Dept. of Nephrology

Tel Aviv, 6423906, Israel

Location

Poria Hospital; Nephrology

Tiberias, Israel

Location

Assaf-Harofeh MC; Nephrology

Zrifin, 70300, Israel

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

continuous erythropoietin receptor activator

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: December 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 15, 2017
• Results First Posted: April 6, 2017

Record last verified: 2017-04

Locations

IL (18)