A Study of Mircera in Anemic Patients With Chronic Kidney Disease Not Yet on Dialysis.

Anemia Clinical Trial

Official title:

An Open-label, Randomized, Multi-centre, Multiple Dose Trial to Investigate the Efficacy and Safety of Subcutaneous Injections of RO0503821 at Different Dosing Intervals in Patients With Chronic Renal Anemia Who Are Not on Renal Replacement Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00048048
• Other study ID #: BA16528
• Status: Completed
• Phase: Phase 2
• First received: October 24, 2002
• Last updated: May 29, 2017
• Start date: March 2002
• Est. completion date: November 2004

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy and safety of different subcutaneous starting doses and dosing frequencies of Mircera in anemic patients with chronic kidney disease not yet on dialysis. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 2004
• Est. primary completion date: October 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• chronic renal anemia;

• not receiving renal replacement therapy.

Exclusion Criteria:

• women who are pregnant, breastfeeding or using unreliable birth control methods;

• administration of any investigational drug within 30 days preceding the screening visit and during the run-in period.

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• methoxy polyethylene glycol-epoetin beta [Mircera]
Differing doses and frequencies of sc administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Canada,  Mexico,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in Hemoglobin Over Time Between Baseline and End of Initial Treatment Based on Individual Regression Slopes	The primary efficacy variable was blood Hb level and its changes from Baseline (defined as the mean Hb of Screening assessment (SA) (Week -3), Weeks -2 and -1 of the Run-in period) over time during the core treatment period. For each participant, the primary efficacy parameter was the change in hemoglobin level over time based on regression slopes. All values until end-of-initial treatment (EOIT), defined as the last observed value before a dose change or blood transfusion, were included in the calculation of this endpoint. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.	From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary	Hematocrit Levels at End of Initial Treatment Under Constant Dosing Regimen	Hematocrit (Hct) levels at end of initial treatment under constant dosing regimen were reported. Baseline (Day -28 to Day 1) Hct values was calculated as the mean of the SA (Week -3) 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, the EOIT value was identical to the value for Week 19.	From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary	Reticulocyte Count at End of Initial Treatment Under Constant Dosing Regimen	Reticulocyte levels at EOIT under constant dosing regimen was analysed and reported. Baseline (Day -28 to Day 1) reticulocyte values were calculated as the mean of the SA (Week -3) and Run-in period (Weeks -2 and -1). For all participants, an EOIT value was calculated as the last observed reticulocyte count before a dose change or blood transfusion. For participants without any dose adjustments, the EOIT value was identical to the value for Week 19.	From Baseline (Day -28 to Day 1) to EOIT (Week 19)
Secondary	Number of Participants With Any Serious Adverse Events and Any Adverse Events	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.	Up to Week 125
Secondary	Number of Participants With Marked Laboratory Abnormalities for Blood Chemistry and Electrolytes Over Time	Marked abnormality was defined as above and/or below a value (according to the Roche specified limits) which was considered to be potentially clinically relevant. The Roche reference range are: white blood cells (WBC) (3.0-18.0 10^9 cells/L), platelets (100-550 10^9 cells/L), alanine aminotransferase (ALT) [0-110 units per litre (U/L)], alkaline phosphatase (ALP) (0-220 U/L), aspartate aminotransferase (AST) (0-80 U/L), albumin >= 30 g/L, phosphate [0.75 - 1.60 millimoles per liter (mmol/L)], potassium (2.9 - 5.8 mmol/L), total bilirubin (0-17 µmol/L), lymphocytes (1- 4.80 10^9 cells/L), eosinophils (0 - 0.45 10^9 cells/L), monocytes (0 - 0.8 10^9 cells/L), and neutrophils (1.80 - 7.70 10^9 cells/L). 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.	Up to Week 125
Secondary	Heart Rate Over Time	Heart rate was defined as the measure of heart beats per minute (bpm). 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.	Up to Week 125
Secondary	Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure	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) values were calculated as the mean of the SA (Week -3) and Run-in period (Week -2 and Week -1).	From Baseline (Day -28 to Day 1) to Week 125