Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

NCT00744445 | Completed Phase 2

• 1 other identifier: 022-1994
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.

Conditions

Hemodialysis; Chronic Renal Failure; Anemia

Keywords

hemodialysis; erythropoietin

Outcome Measures

Primary Outcomes (1)

• Time for hematocrit to rise

Study Arms (3)

0800

ACTIVE COMPARATOR

r-HuEPO administered at 0800 hrs

Drug: r-HuEPO

1500

ACTIVE COMPARATOR

r-HuEPO administered at 1500 hrs

Drug: r-HuEPO

2200

ACTIVE COMPARATOR

r-HuEPO administered at 2200 hrs

Drug: r-HuEPO

Interventions

r-HuEPO DRUG

r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.

0800; 1500; 2200

Eligibility Criteria

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

You may qualify if:

• Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
• Serum ferritin level \> 200 micrograms/L and transferrin saturation \> 15%
• Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
• Prior therapy with r-HuEPO
• An adequate program of dialysis established
• Informed consent signed

You may not qualify if:

• Adocumented cause of anemia other than chronic renal disease
• Symptoms of unstable coronary artery disease
• Poorly controled hypertension
• Known seizure disorder
• Other active inflammatory or infective disorders
• Other disorders that may diminish the response of the bone marrow to r-HuEPO

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

MeSH Terms

Conditions

Kidney Failure, Chronic; Anemia

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; 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)

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

• Georg Bjarnason, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2008
• First Posted: September 1, 2008
• Study Start: October 1, 1993
• Primary Completion: August 1, 1998
• Study Completion: August 1, 1998
• Last Updated: September 1, 2008

Record last verified: 2008-08