A Study to Evaluate PROCRIT (Epoetin Alfa) for Maintenance Phase Treatment of Patients With Anemia Due to Chronic Kidney Disease (PROMPT)

NCT00307814 | Completed Phase 2

• 1 other identifier: CR005101
• Study Type: interventional
• Target: 519
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of less frequent dosing of PROCRIT (Epoetin alfa) in patients with anemia due to Chronic Kidney Disease (CKD) as assessed by hemoglobin maintenance, adverse events and health-related quality of life.

Conditions

Anemia; Chronic Renal Insufficiency

Keywords

Anemia; Low Blood Count; Chronic Kidney Failure; Chronic Kidney Disease; epoetin alfa; recombinant human erythropoietin

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is hemoglobin maintenance. Also, patients will be assessed for incidence and severity of adverse events and vital signs (blood pressure) during the 16 week study period.

Secondary Outcomes (1)

• The secondary variable is Quality of Life and Hemoglobin Change over Time

Interventions

Epoetin Alfa DRUG

Eligibility Criteria

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

You may qualify if:

• CKD patients (defined as serum creatinine 1.5 to 6.0 mg/dL for women and 2.0 to 6.0 g/mg/dL for men)
• Stable Hb (\>= 11.0g/dL) and currently receiving PROCRIT therapy for 2 months or more. A stable Hemoglobin will be defined as a value that is ± 10% for 3 consecutive laboratory values.

You may not qualify if:

• Lactating or pregnant women
• Uncontrolled hypertension
• Known hypersensitivity to mammalian cell-derived products and human albumin
• Receiving dialysis or scheduled to receive dialysis during the course of the study
• gastrointestinal bleeding
• Severe Congestive Heart Failure (New York Heart Association Class IV)
• Concurrent chemotherapy for cancer
• History of/or active blood disorders, liver diseases or seizures
• HIV positive
• Received a kidney transplant

Sponsors & Collaborators

• Ortho Biotech Products, L.P.: lead

Related Publications (1)

• Provenzano R, Bhaduri S, Singh AK; PROMPT Study Group. Extended epoetin alfa dosing as maintenance treatment for the anemia of chronic kidney disease: the PROMPT study. Clin Nephrol. 2005 Aug;64(2):113-23. doi: 10.5414/cnp64113.

  PMID: 16114787 RESULT

Related Links

• A Randomized, Open-label Clinical Evaluation of PROCRIT (Epoetin ala) for Maintenance Phase Treatment of Patients with Anemia due to Chronic Kidney Disease (PROMPT Study)

MeSH Terms

Conditions

Anemia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; 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

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

Study Officials

• Ortho Biotech Products, L.P. Clinical Trial

  Ortho Biotech Products, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 28, 2006
• Study Start: January 1, 2002
• Study Completion: January 1, 2004
• Last Updated: May 19, 2011

Record last verified: 2010-04