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AnemiaPhase 2NCT00048035

A Study of Intravenous (iv) Mircera in Hemodialysis Patients With Chronic Renal Anemia

A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
methoxy polyethylene glycol-epoetin beta [Mircera]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
14 sitesUnited States
Study dates
Mar 2002to Jun 2005
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on hemodialysis therapy for at least 3 months;
  • receiving iv epoetin alfa during the 2 weeks prior to the run-in period.

Who cannot join

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • use of any investigational drug within 30 days of the run-in phase, or during the run-in or study treatment period.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Study site

    Birmingham, Alabama, 35211

  • Study site

    Brooklyn, New York, 11203

  • Study site

    Brooklyn Center, Minnesota, 55430

  • Study site

    Detroit, Michigan, 48202-2689

  • Study site

    Detroit, Michigan, 48236

  • Study site

    Las Vegas, Nevada, 89106

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202-1718

  • Study site

    Maywood, Illinois, 60153

  • Study site

    Mineola, New York, 11501

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New York, New York, 10128

  • Study site

    Paterson, New Jersey, 07503

Other trials in United States

About this study

Official title: An Open-label, Multicenter, Randomized Study to Determine Dose Conversion Factors at Different Frequencies of Administration After Switching From Maintenance Treatment With Intravenous Epoetin Alfa to Maintenance Treatment With Intravenous RO0503821 in Hemodialysis Patients With Chronic Renal Anemia.

This study will determine the appropriate dose and frequency of administration of iv Mircera maintenance therapy in hemodialysis patients with chronic renal anemia who were previously receiving iv epoetin. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Conditions
Anemia
Being tested
methoxy polyethylene glycol-epoetin beta [Mircera]
Medical subject headings
Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methoxy polyethylene glycol-epoetin beta [Mircera]Drug

    Differing doses and frequencies of iv administration

Study groups in NCT00048035
Study groupRoleWhat they receive
Cohort 1 (RO0503821 [0.25/150 1x/week])ExperimentalEligible participant will be administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV) using a dose conversion factor of 0.25/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 62.50% 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort 2 (RO0503821 [0.25/150 1x/2week])ExperimentalEligible participant will be administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort 3 (RO0503821 [0.4/150 1x/week])ExperimentalEligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort 4 (RO0503821 [0.4/150 1x/2week])ExperimentalEligible participant will be administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort 5 (RO0503821 [0.6/150 1x/week])ExperimentalEligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Cohort 6 (RO0503821 [0.6/150 1x/2week])ExperimentalEligible participant will be administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two 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).
Receives: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Change From Baseline in Hemoglobin Levels to End of Initial Treatment Under Constant Dosing Regimen

    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 Week -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 value.

    Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

Secondary outcomes (5)

  1. Median Change From Baseline in Hematocrit Levels to End of Initial Treatment Under Constant Dosing Regimen

    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 value.

    Measured: From Baseline (Day -28 to Day 1) to EOIT (Week 19)

  2. Number of Participants With Any Adverse Events, Any Serious Adverse Events, And Deaths

    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.

    Measured: Up to Week 126

  3. Number of Participants With Marked Laboratory Abnormalities

    Marked abnormality was defined as above and/or below a value which was considered to be potentially clinically relevant. The number of participants with marked lab abnormality across treatment groups were reported and presented. Marked laboratory abnormalities were analyzed according to the Roche specified limits for the following reference range: White blood cells (WBC) (3.0- 18.0 10^9/L), Platelets (100 - 550 10^9/L), Alanine aminotransferase (ALAT) [0 110 units per litre (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).

    Measured: Up to Week 126

  4. Mean Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure Before and After Dialysis

    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) values were calculated as the mean of the screening assessment (SA) and run-in period (Week -2 and Week -1).

    Measured: From Baseline (Day -28 to Day 1) to Week 126

  5. Mean Change in Pulse Rate

    Participants pulse rates in beats per minute (BpM) were analyzed at sitting position using descriptive statistical methods (ie, means, standard deviations and percentiles). The changes in pulse rate throughout the study were analysed at each study visit and mean change is reported.

    Measured: Up to Week 126

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2002 (estimated)
  2. Study startMar 2002
  3. Primary completionJun 2005
  4. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00048035
Sponsor's protocol ID
BA16285
Status last verified
Oct 2016
First submitted
24 Oct 2002
Last updated
20 Dec 2016

Publications

  • Natale P, Ju A, Strippoli GF, Craig JC, Saglimbene VM, Unruh ML, Stallone G, Jaure A. Interventions for fatigue in people with kidney failure requiring dialysis. Cochrane Database Syst Rev. 2023 Aug 31;8(8):CD013074. doi: 10.1002/14651858.CD013074.pub2.

    PubMed 37651553

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PubMed 36791280

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing methoxy polyethylene glycol-epoetin beta [Mircera] in people with Anemia, run by Hoffmann-La Roche at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00048035, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2016.

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