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Clinical Trial Details

Trial ID: L0076
Source ID: NCT02238080
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Title: An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis
Acronym: IMPACT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02238080/results
Conditions: Chronic Kidney Diseases
Interventions: DRUG: Methoxy Polyethylene Glycol-Epoetin Beta
Outcome Measures: Primary: 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: 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)., 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, Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r)., 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)., 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|Serum Hemoglobin Level, Baseline, Month 6
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 197
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2009-12
Completion Date: 2012-06
Results First Posted: 2017-04-06
Last Update Posted: 2017-05-15
Locations: Haemek Hospital; Nephrology, Afula, 18101, Israel|Barzilai Medical Centre ; Nephrology and Hypertension, Ashkelon, 78306, Israel|Soroka Medical Center; Nephrology, Beer Sheva, 84101, Israel|Bnai Zion MC; Nephrology, Haifa, 31048, Israel|Carmel Medical Center; Nephrology, Haifa, 34362, Israel|Wolfson MC; Nephrology, Holon, 58100, Israel|Shaare Zedek Medical Center; Nrphrology Dept., Jerusalem, 91031, Israel|Hadassah Medical Orgainastion; Nephrology, Jerusalem, 91120, Israel|Meir Medical Center; Nephrology Dept., Kfar Saba, 44281, Israel|Western Galilee Hospital; Nrphrology Dept., Nahariya, 22100, Israel|EMMS Nazareth; Nephrology, Nazareth, 16100, Israel|Holy Family Hospital; Nephrology, Nazareth, 16100, Israel|Beilinson Medical Center; Nephrology, Petach Tikva, 49100, Israel|Sheba MC; Nephrology, Ramat-Gan, 52621, Israel|Rebecca Sief Hospital; Nephrology, Safed, 13100, Israel|Sourasky MC; Dept. of Nephrology, Tel Aviv, 6423906, Israel|Poria Hospital; Nephrology, Tiberias, Israel|Assaf-Harofeh MC; Nephrology, Zrifin, 70300, Israel
URL: https://clinicaltrials.gov/show/NCT02238080