Renal Insufficiency, ChronicPhase 4NCT02253654

Evaluation of Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

A Phase 4 study testing Epoetin alfa in people with Renal Insufficiency, Chronic and Anemia, run by Amgen at 37 sites in 2 countries.

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

The purpose of this study is to compare two different dosing methods of epoetin alfa and their effectiveness in maintaining hemoglobin levels between 10.0 to 11.0 g/dL in in patients with chronic kidney disease (CKD) receiving hemodialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Renal Insufficiency, Chronic, Anemia, Renal Dialysis
What is being tested?: Epoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 216 participants
Where: 37 sitesin 2 countries
Study dates: 1 Apr 2015to 25 May 2016
Phase: Phase 4
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

Informed consent obtained prior to initiation of any study-specific activities/procedures
Age 18 or older
Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and < 90,000 Units/week (ie, < 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization
Received ≥ 4 doses of epoetin alfa during the 2 weeks prior to randomization

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Hemoglobin concentration ≤ 11.0 g/dL, per the most recent local laboratory value obtained during the 2 weeks prior to randomization
Hemoglobin concentration ≤ 11.0 g/dL, at the screening visit, using the hemoglobin point of care device provided by Amgen
Iron replete, defined as a transferrin saturation (TSAT) ≥ 20% and a ferritin ≥ 100 ng/mL, per the most recent local laboratory value obtained during the 4 weeks prior to randomization

Who cannot join

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to randomization
Other investigational procedures while participating in this study are excluded
Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
Subject is currently pregnant or planning to become pregnant during treatment and for 30 days after the end of treatment

Show all 24Show fewer

Subject is currently breast feeding or planning on breast feeding during treatment and for 30 days after the end of treatment
Females of reproductive potential who are not willing to use an acceptable method of effective contraception during treatment and for at least 30 days after the end of treatment
Currently receiving IV antibiotics
Currently receiving systemic immunosuppressive therapy known to cause anemia, including treatment for active hepatitis (eg, azathioprine, mycophenolate mofetil, ≥ 10 mg prednisone [or equivalent]/day, interferon)
Known human immunodeficiency virus (HIV) positive
Known neutralizing anti-erythropoietic protein antibodies
Known sensitivity to epoetin alfa
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, planned vacations where away from dialysis unit for more than 2 weeks) to the best of the subject and investigator's knowledge
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
Previously entered this study
Occurrence of any of the following within 8 weeks prior to randomization:
Seizure
Clinically relevant active bleeding (eg, gastrointestinal bleed)
RBC transfusion
Any hospitalization or observational stay > 24 hours
Uncontrolled hypertension, per the investigator within the 4 weeks prior to randomization
Expected or scheduled solid organ transplant(eg, kidney) within 40 weeks after randomization
Expected or scheduled to change dialysis modality (eg, peritoneal dialysis, home hemodialysis) within 40 weeks after randomization

Trial locations and contacts

37 sites in 2 countries.

Country

City, postcode or hospital

37 sites in 2 countries

United States36 sites

Research Site
Astoria, New York, 11102
Research Site
Brooklyn, New York, 11235
Research Site
Burlington, Vermont, 05401
Research Site
Carrboro, North Carolina, 27510
Research Site
Cerritos, California, 90703
Research Site
Detroit, Michigan, 48202
Research Site
Glendale, California, 91204
Research Site
Hampton, Virginia, 23666
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77070
Research Site
Kansas City, Missouri, 64111
Research Site
Lincoln, Nebraska, 68510
Research Site
Los Angeles, California, 90022
Research Site
Los Angeles, California, 90057
Research Site
Macon, Georgia, 31217
Research Site
Meadville, Pennsylvania, 16335
Research Site
Merrillville, Indiana, 46410
Research Site
Miami, Florida, 33150
Research Site
Miami Gardens, Florida, 33169
Research Site
Michigan City, Indiana, 46360
Research Site
Montebello, California, 90640
Research Site
Norfolk, Virginia, 23502
Research Site
Pembroke Pines, Florida, 33025
Research Site
Philadelphia, Pennsylvania, 19106
Research Site
Pontiac, Michigan, 48341
Research Site
Riverside, California, 92501
Research Site
Rosedale, New York, 11422
Research Site
Roseville, Michigan, 48066
Research Site
San Antonio, Texas, 78229
Research Site
San Diego, California, 92115
Research Site
Simi Valley, California, 93065
Research Site
Statesboro, Georgia, 30458
Research Site
The Bronx, New York, 10461
Research Site
Vacaville, California, 95687
Research Site
Whittier, California, 90606
Research Site
Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico1 site

Research Site
Toa Baja, 00949

Other trials in Puerto Rico

About this study

Official title: A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis

Conditions: Renal Insufficiency, Chronic, Anemia, Renal Dialysis, Erythrocyte Transfusion
Being tested: Epoetin alfa
Keywords: Chronic Kidney Disease, Anemia, Hemodialysis, Red Blood Cell Transfusion
Medical subject headings: Renal Insufficiency, Chronic, Anemia

What participants receive

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

Epoetin alfaDrug
Also called Epogen
Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.

Study groups in NCT02253654
Study group	Role	What they receive
Epoetin alfa Alternative Titration	Experimental	Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories. Receives: Drug: Epoetin alfa
Epoetin alfa USPI Titration	Active comparator	Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels. Receives: Drug: Epoetin alfa

What is being measured

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

Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.
Measured: The evaluation period (weeks 13-37)

Secondary outcomes (7)

Hemoglobin Concentration at Each Visit
Measured: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Percentage of Participants With Transfusion Events Overall and During Each Study Period
The percentage of participants who received red blood cell (RBC) transfusions during the study and during each study period.
Measured: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
Hemoglobin Rate of Change at Each Visit
Hemoglobin rate of change (ROC) was calculated for each visit using the following formula: ROC = (current visit hemoglobin value - previous visit hemoglobin value) / number of days between each visit * 14. A positive value indicates a rate of rise and a negative value indicates a rate of decline.
Measured: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Hemoglobin Intra-subject Variability
Intra-subject variability was defined for each participant as the standard deviation (SD) of all of the hemoglobin concentrations during the evaluation period for the participant. The mean intra-subject SD for all participants is the sum of the intra-subject SDs divided by the total number of participants evaluated.
Measured: The evaluation period (weeks 13 to 37)
Percentage of Participants With Hemoglobin Excursions at Each Visit
An excursion is identified as an event when a hemoglobin concentration fell below or exceeded the pre-specified thresholds of: - < 9.0 g/dL, or - > 11.0 g/dL, or - > 12.0 g/dL. The percentage of participants with any excursions and excursions in each subcategory at each time point and overall during the study are reported.
Measured: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Weekly Epoetin Alfa Dose at Each Visit
Measured: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Number of RBC Units Transfused Overall and During Each Study Period
The number of red blood cell (RBC) units transfused during the study and during each study period.
Measured: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

Timeline

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

1 Apr 201525 May 2016

First posted1 Oct 2014 (estimated)
Study start1 Apr 2015
Primary completion27 Apr 2016
Study completion25 May 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 216 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02253654
Sponsor's protocol ID: 20110208
Status last verified: May 2017
First submitted: 11 Sep 2014
Last updated: 19 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Multicenter, Double-blind Study Evaluating Two Epoetin Alfa Dosing Strategies in Subjects With Chronic Kidney Disease Receiving Hemodialysis
ClinicalTrials.gov ID: NCT02253654
Acronym / sponsor ID: 20110208
Conditions: Renal Insufficiency, Chronic, Anemia, Renal Dialysis, Erythrocyte Transfusion
Keywords: Chronic Kidney Disease, Anemia, Hemodialysis, Red Blood Cell Transfusion
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 216 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Apr 2015 (actual)
Primary completion: 27 Apr 2016 (actual)
Study completion: 25 May 2016 (actual)
First posted: 1 Oct 2014 (estimated)
Results: Posted 12 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Epoetin alfa Alternative Titration	Experimental	Drug: Epoetin alfaParticipants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
Epoetin alfa USPI Titration	Active comparator	Drug: Epoetin alfaParticipants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Informed consent obtained prior to initiation of any study-specific activities/procedures
Age 18 or older
Prescribed hemodialysis three times a week (TIW) for ≥ 12 weeks prior to randomization
Prescribed IV administration of epoetin alfa TIW for ≥ 12 weeks prior to randomization
Prescribed ≥ 3000 Units/week (ie, ≥ 1000 Units/administration) and < 90,000 Units/week (ie, < 30,000 Units/administration) of epoetin alfa during the 4 weeks prior to randomization

Key exclusion criteria (24 listed)

Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to randomization
Other investigational procedures while participating in this study are excluded
Systemic hematologic disease (eg, sickle cell anemia, myelodysplastic syndrome, hematologic malignancy)
Current or prior malignancy within 5 years of randomization, with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ
Treatment for any malignancy (eg, radiation, chemotherapy, hormone therapy or biologics) within 5 years of randomization, with the exception of locally excised non-melanoma skin cancers, cervical or breast ductal carcinoma in situ

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epoetin alfaAlso: EpogenAdministered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.	Drug	Epoetin alfa Alternative Titration, Epoetin alfa USPI Titration

Primary outcome

Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period
Time frame: The evaluation period (weeks 13-37)
Hemoglobin was measured every 2 weeks during the evaluation period. The percentage of these measurements that were within the range of 10-11 g/dL was calculated for each participant.

7 secondary outcomes

Hemoglobin Concentration at Each Visit
Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Percentage of Participants With Transfusion Events Overall and During Each Study Period
Time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41
Hemoglobin Rate of Change at Each Visit
Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Hemoglobin Intra-subject Variability
Time frame: The evaluation period (weeks 13 to 37)
Percentage of Participants With Hemoglobin Excursions at Each Visit
Time frame: Baseline (screening visit) and weeks 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, and 37
Weekly Epoetin Alfa Dose at Each Visit
Time frame: Weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35
Number of RBC Units Transfused Overall and During Each Study Period
Time frame: Overall Study: Study week 1 to week 41; Titration Period: Study week 1 to week 12; Evaluation Period: Study week 13 to week 37; Safety Follow-up Period: Study week 38 to week 41

Results and safety

Results posted to the registry on 12 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epoetin Alfa Alternative Titration	108	85
Epoetin Alfa USPI Titration	108	90

Primary outcome: Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period

Time frame: The evaluation period (weeks 13-37). Mean (Standard Deviation). Unit: percentage of hemoglobin measurements

Measure	Epoetin Alfa Alternative Titration n = 89	Epoetin Alfa USPI Titration n = 100
Value	46.41 (2.39)	46.02 (2.56)

Epoetin Alfa Alternative Titration vs Epoetin Alfa USPI Titration: Treatment difference: 0.39, p = 0.46, t-test, 1 sided

Population analysed: The Primary Analysis Set which consists of all randomized participants who had at least 6 hemoglobin measurements during the evaluation period while on study and receiving investigational product.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 41 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epoetin Alfa Alternative Titration	37 of 104 (35.6%)	19 of 104 (18.3%)	Not reported
Epoetin Alfa USPI Titration	39 of 107 (36.4%)	26 of 107 (24.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

37 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Epoetin alfa in people with Renal Insufficiency, Chronic and Anemia, run by Amgen at 37 sites in 2 countries.

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 9 inclusion and 24 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 12 May 2017). 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?

Percentage of Hemoglobin Measurements Within 10 to 11 g/dL During the Evaluation Period (time frame: The evaluation period (weeks 13-37)). 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 NCT02253654.

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 19 May 2017.