Completed

A Study of Subcutaneous Mircera for the Treatment of Anemia in Dialysis Patients.

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What is being tested

epoetin alfa or beta

+ methoxy polyethylene glycol-epoetin beta (Mircera)
Drug
Who is being recruted

Anemia

Over 18 Years
+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2004

See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: May 25, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

This study will assess the efficacy and safety of subcutaneous (sc) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving sc epoetin. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Official TitleA Randomized, Controlled, Open-Label, Multi- Center, Parallel-Group Study to Demonstrate the Efficacy and Safety of RO0503821 When Administered Subcutaneously for the Maintenance Treatment of Anemia in Patients With Chronic Kidney Disease Who Are on Dialysis 
Principal SponsorHoffmann-La Roche
Last updated: May 25, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
572 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anemia
Criteria
4 inclusion criteria required to participate
adult patients >=18 years of age
chronic renal anemia
on dialysis therapy for at least 12 weeks before screening
receiving sc epoetin for at least 8 weeks before screening
2 exclusion criteria prevent from participating
women who are pregnant, breastfeeding or using unreliable birth control methods
administration of another investigational drug within 4 weeks before screening, or during the study period

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug.
Group II
Experimental
Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug.
Group III
Active Comparator
Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks .
Study Objectives
Primary Objectives

A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
Secondary Objectives

All mean Hb values recorded during the evaluation period were calculated and subtracted from the mean baseline Hb value for each participant. The number of participants maintaining their average Hb within +/- 1 g/dL of their average baseline hemoglobin concentration is given. The evaluation period is defined as Week 29 to Week 36.

The number of participants who received RBC transfusions were reported.

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

A marked abnormality range was defined as above and/or below a value which was considered to be potentially clinically relevant. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the reference range of the following laboratory parameters: White blood cells (WBC) (3.0- 18.0 10\^9/L), platelets (100 - 550 10\^9/L), alanine aminotransferase (ALAT) (0 - 110 units per liter \[U/L\]), alkaline phosphatase (ALP \[0 - 220 U/L\]), aspartate aminotransferase (ASAT) (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), glucose (2.80 - 11.10 mmol/L).

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in haemodialysis participants.

Pulse rate in beats per minute (BpM) was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in haemodialysis participants.

Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in sitting position before and after dialysis session in peritoneal dialysis participants.

Pulse rate in BpM was measured at each study visit, i.e., once a week during the dose titration and evaluation periods, once every two weeks during the long-term safety observation period and at the final visit. It was measured before blood sampling and RO0503821/epoetin administration and before the dialysis session in peritoneal dialysis participants.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 90 locations
Suspended
Unknown FacilityHot Springs, United StatesSee the location
Suspended
Unknown FacilityLos Angeles, United States
Suspended
Unknown FacilityRiverside, United States
Suspended
Unknown FacilitySacramento, United States
Completed90 Study Centers