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AnemiaPhase 4NCT00211120

Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR)

A Phase 4 study testing Epoetin Alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anemia
What is being tested?
Epoetin Alfa
How many people
1,432 participants
Where
No sites listed yet
Study dates
Mar 2002to Aug 2005
Phase
Phase 4
Are there results?
None posted in the registry

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

  • Chronic Kidney Disease:Glomerular filtration rate (GFR) > 15 mL/min and > 50 mL/min as calculated by the central lab. HB<11 g/dL upon study enrollment. The GFR for assessment of patient eligibility will be determined using the formula derived from the Modification of Diet for Renal Disease (MDRD) Study.

Who cannot join

  • Pregnant or lactating women
  • Presence of uncontrolled hypertension
  • Known hypersensitivity to mammalian cell-derived products or human albumin
  • Active gastrointestinal bleeding
  • Iron overload defined as a transferrin saturation >70% or ferritin >1000 ng/mL
  • History of frequent blood transfusions in the past 6 months
Show all 15Show fewer
  • Unstable angina or angina pectoris at rest
  • Severe chronic obstructive pulmonary disease requiring routine use of supplemental oxygen
  • Severe liver dysfunction that is defined by an international normalized ratio >2.0, not caused by an anticoagulant
  • Severe malnutrition
  • Active hematological disease (eg, sickle cell anemia, thalassemia)
  • Active malignancy (usually defined as malignancy requiring current chemotherapy or radiotherapy)
  • Patients with current seizure disorder or activity
  • Patients currently receiving RRT (patient can not be on dialysis or have had a kidney transplant)
  • Patients who have received Epoetin Alpha within 6 weeks prior to study entry

About this study

Official title: Correction of Hemoglobin and Outcomes In Renal Insufficiency

The purpose of this study is to compare the outcomes of patients with chronic kidney disease (CKD) randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity.

Read the detailed description

This is a prospective, open-label, randomized, multi-center study in patients with CKD. Patients who meet the selection criteria will be randomly assigned to one of two treatment arms: GROUP A: PROCRIT® (Epoetin alfa) therapy directed at maintaining the hemoglobin level as close to 13.5 g/dL as possible (may be slightly higher or lower) or GROUP B: PROCRIT® (Epoetin alfa) therapy directed at maintaining the hemoglobin level as close to 11.3 g/dL as possible (may be slightly higher or lower).

Patients will receive weekly doses of PROCRIT® (Epoetin alfa). Subsequent doses of PROCRIT® will be given weekly as needed with dose adjustments made to maintain the hemoglobin (Hb) as close to the target level as possible until the initiation of Renal Replacement Therapy (RRT) or 36 months, whichever comes first.

The purpose of this study is to compare the outcomes of patients with CKD randomly assigned to 2 treatment groups, which differ only in their targeted hemoglobin levels. This study will test the primary hypothesis that the level of anemia correction with once weekly dosing of PROCRIT® (Epoetin alfa) in patients with chronic kidney disease will decrease mortality and cardiovascular morbidity. Patients will receive a starting dose of PROCRIT® 10,000 Units (U) subcutaneously (SC) 1x / week. After 3 weekly doses, subsequent doses and dosing intervals of PROCRIT®, up to a maximum dose of 20,000 U for 36 months, will be adjusted based on an assessment of the two most recent hemoglobin values.

Conditions
Anemia
Being tested
Epoetin Alfa
Keywords
Anemia, Low Blood Count, Chronic Kidney Failure, Chronic Kidney Disease
Medical subject headings
Anemia, Kidney Failure, Chronic, Renal Insufficiency, Chronic

What participants receive

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

  • Epoetin AlfaDrug

What is being measured

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

  1. The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs)

Secondary outcomes (1)

  1. All cause mortality; Myocardial infarction; Stroke; RRT;CHF, Cardiovascular and all cause hospitalizations, Change from baseline in hemoglobin, Quality of Life Scores (SF36, KDQ, LASA), transfusions

Timeline

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

  1. First posted21 Sep 2005 (estimated)
  2. Study startMar 2002
  3. Study completionAug 2005

Why it stopped: Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and \<5% chance that the study would show benefit for higher Hb.

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,432 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00211120
Sponsor's protocol ID
CR004588
Status last verified
Mar 2010
First submitted
13 Sep 2005
Last updated
18 May 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Singh AK, Szczech L, Tang KL, Barnhart H, Sapp S, Wolfson M, Reddan D; CHOIR Investigators. Correction of anemia with epoetin alfa in chronic kidney disease. N Engl J Med. 2006 Nov 16;355(20):2085-98. doi: 10.1056/NEJMoa065485.

    PubMed 17108343

  • 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 4 study testing Epoetin Alfa in people with Anemia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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 1 inclusion and 15 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: stopped early, as of the sponsor's last update on 18 May 2011. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was stopped early (reason given: Stopped by the DSMB due to a trend toward more adverse events in the higher hemoglobin (Hb) arm and \<5% chance that the study would show benefit for higher Hb.). Results are not available in the source record.

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?

The primary outcome will be a composite consisting of mortality (all cause), myocardial infarction, stroke, and CHF hospitalization (not including those hospitalizations during which RRT occurs). 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 NCT00211120, 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 18 May 2011.

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