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A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00364832
First received: August 15, 2006
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Subcutaneous Epoetin Alfa or Beta to Maintenance Treatment With Subcutaneous RO0503821 in Dialysis Patients With Chronic Renal Anemia

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen [ Time Frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) ]
    Median change from Baseline in hemoglobin (Hb) levels to end of initial treatment (EOIT) under constant dosing regimen was reported. For ease of interpretation, all individual slope values were multiplied by 42 to give an estimate of change in Hb values over six weeks. Baseline (Day -28 to Day 1) Hb values was calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and -1). For all participants, an EOIT value was calculated as the last observed Hb value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.


Secondary Outcome Measures:
  • Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen [ Time Frame: From Baseline (Day -28 to Day 1) to EOIT (Week 19 or Week 21) ]
    Median change from Baseline in hematocrit (Hct) levels to end of initial treatment under constant dosing regimen was reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA and run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed Hct value before a dose change or blood transfusion. For participants without any dose adjustments or blood transfusion, the EOIT value was identical to the Week 19 (or Week 21) value.

  • Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis [ Time Frame: From Baseline (Day -28 to Day 1) to Week 126 ]
    Mean Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) is calculated as the end of treatment values minus the Baseline value. Baseline (Day -28 to Day 1) value is the measurements taken at screening assessment and run-in period (Weeks -2 and -1).

  • Mean Change in Pulse Rate [ Time Frame: Up to Week 126 ]
    Mean change in pulse rate was reported.

  • Number of Participants With Marked Laboratory Abnormalities [ Time Frame: Up to Week 126 ]
    Participants with marked laboratory abnormalities were reported. Marked abnormality criteria: Serum glutamic oxaloacetic transaminase (SGOT); high >25 units per litre (U/L), albumin (low < 31 grams per litre [g/L]), total protein (< 60 g/L), phosphate (high >1.45 millimoles per litre [mmol/L]); Low <0.84 mmol/L), potassium (high >5 mmol/L; Low <3.5 mmol/L), platelets (low:<150×10^9/L), White blood cells ([WBCs]); high: 10.8×10^9/L and Low:4.3×10^9/L), basophils (high:>0.15×10^9/L), eosinophils (high:>0.70×10^9/L), lymphocytes (low:<1.50×10^9/L), and neutrophils (low:<1.83×10^9/L).

  • Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths [ Time Frame: Up to Week 126 ]
    An Adverse Events (AEs) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Events (SAEs) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event in the investigator's judgment or requires intervention to prevent one or other of these outcomes. The study design tested 3 different starting dose conversion factors at 3 different dosing schedules during the core study period. As study drug doses can be modified continually over time all results for the two long term safety periods were displayed by dose schedule group only.


Enrollment: 137
Study Start Date: October 2001
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A (0.4/150, 1x/ Week)
Eligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) SC using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort B (0.4/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort C (0.4/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort D (0.8/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort E (0.8/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort F (0.8/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort G (1.2/150, 1x/ Week)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort H (1.2/150, 1x/ 3 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration
Experimental: Cohort I (1.2/150, 1x/ 4 Weeks)
Eligible participant will be administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants will be followed-up for two optional treatment extension periods (54 weeks each).
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
  • receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364832

Locations
United States, California
Los Angeles, California, United States, 90073
San Jose, California, United States, 95116-1906
United States, Massachusetts
Boston, Massachusetts, United States, 02130
United States, Ohio
Cleveland, Ohio, United States, 44106
United States, Texas
Houston, Texas, United States, 77030
United States, West Virginia
Morgantown, West Virginia, United States, 26506
Germany
Berlin, Germany, 10625
Mannheim, Germany, 68167
Villingen-schwenningen, Germany, 78054
Wiesloch, Germany, 69168
Italy
Bari, Italy, 70124
Bergamo, Italy, 24128
Lecco, Italy, 23900
Lodi, Italy, 26900
Milano, Italy, 20122
Modena, Italy, 41100
Pavia, Italy, 27100
Vicenza, Italy, 36100
Spain
Barcelona, Spain, 08036
Madrid, Spain, 28007
Madrid, Spain, 28046
Malaga, Spain, 29010
Santander, Spain, 39008
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00364832     History of Changes
Other Study ID Numbers: BA16286 
Study First Received: August 15, 2006
Results First Received: May 3, 2016
Last Updated: October 26, 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on February 23, 2017