A Study of the Use of PROCRIT (Epoetin Alfa) for the Treatment of Anemia in People With Chronic Kidney Disease Who Live in Long-term Care Facilities.

NCT00337935 | Completed Phase 2 Results

• 1 other identifier: CR012229
• Study Type: interventional
• Target: 157
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to show that giving PROCRIT (Epoetin alfa) every 2 weeks to increase the hemoglobin (Hb) level and then to adjust the PROCRIT (Epoetin alfa) dose every 4 weeks (Q4W) to maintain Hb levels, is safe and effective in patients with anemia from Chronic Kidney Disease (CKD), not on dialysis, who reside in long-term care facilities. In this study the frequency of PROCRIT (Epoetin alfa) dosing is under investigation.

Conditions

Renal Failure , Chronic; Anemia

Keywords

Long Term Care Facilities; subcutaneous injections; PROCRIT; Epoetin alfa; Anemia

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hemoglobin Level From Baseline to the End of Study (26 Weeks)

  Week 0 to Week 26

Secondary Outcomes (2)

• The Number of Patients Achieved a Hemoglobin Response.

  Week 0 to Week 26

• Time to Hemoglobin Response

  Week 0 to Week 26

Study Arms (2)

Epoetin Alfa

EXPERIMENTAL

Drug: Epoetin Alfa

Group 2

OTHER

Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).

Other: Standard of care

Interventions

Epoetin Alfa DRUG

Epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks

Epoetin Alfa

Standard of care OTHER

Also known as: Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs).

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Kidney Disease (CKD) Stage 3, 4, or 5 (not on dialysis), Glomerular Filtration Rate (GFR) \[\<60 mL/min/1.73 m2\], or CKD Stage 2 (GFR 61-90 mL/min/1.73 mm2) with evidence of kidney damage (defined as structural or functional abnormalities of the kidneys) for greater than 3 months
• Hb \<11 g/dL measured at screening and a stable creatinine over the last 3 months
• expected to stay in a Long Term Care (LTC) facility for at least six months
• not receiving erythropoietic agents within eight weeks prior to screening.

You may not qualify if:

• No significant hematological disease (including, but not limited to, myelodysplastic syndrome, hematological malignancy, hemolytic syndromes, hemoglobinopathy), or with a current diagnosis of anemia due to blood loss (e.g., hemolysis or gastrointestinal bleeding) or any cause of anemia other than CKD (e.g., hypothyroidism, HIV)
• No uncontrolled or severe cardiovascular disease including uncontrolled hypertension (systolic BP \> 170 mm/Hg, or diastolic BP \> 100 mm/Hg), or congestive heart failure (New York Heart Association (NYHA) Class IV)
• No known solid tumor malignancy, receiving chemotherapy for cancer or having major surgery within one month prior to screening or expected during study participation
• No history of receiving a transplanted organ, or scheduled to receive an organ transplant during the course of the study, with the exception of a corneal transplant.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

Related Publications (1)

• 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.

  PMID: 36791280 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anemia

Interventions

Epoetin Alfa; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Centocor Ortho-Biotech LLC.

800.457.6399

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2006
• First Posted: June 20, 2006
• Study Start: July 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: May 13, 2013
• Results First Posted: May 13, 2013

Record last verified: 2013-05