STAAR-2 Clinical Study

NCT00368901 | Completed Phase 4

• 1 other identifier: 20010215
• Study Type: interventional
• Target: 618
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the effect of Aranesp on the hemoglobin (Hgb) of CRI subjects who are recombinant human erythropoietin (rHuEPO)-naïve or converting from rHuEPO therapy.

Conditions

Chronic Kidney Disease; Chronic Renal Insufficiency; Kidney Disease; Pre-dialysis; Pre-ESRD

Keywords

Aranesp; Anemia; Kidney Disease; Hemoglobin; darbepoetin alfa; QoL

Outcome Measures

Primary Outcomes (1)

• Mean hemoglobin during the evaluation period

  52 weeks

Secondary Outcomes (5)

• Change in hemoglobin throughout the study

  52 weeks

• HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study

  52 weeks

• Health-related resource utilization, measured every 4 weeks, throughout the study

  52 weeks

• Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12

  12 weeks

• Iron requirement (dose, frequency, and route) of subjects during the study

  52 weeks

Study Arms (1)

Single arm

EXPERIMENTAL

Every other week dosing of Aranesp SC

Drug: Darbepoetin alfa

Interventions

Darbepoetin alfa DRUG

Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL

Also known as: Aranesp

Single arm

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years old
• diagnosis of CRI and not receiving dialysis therapy (must be predialysis)
• measured or estimated (using the Cockcroft-Gault formula) creatinine clearance (CrCl) of ≤ 70 mL/min, or GFR ≤ 60 mL/min (using the MDRD formula):
• Cockcroft-Gault formula: CrCl = (140 minus age in years) x (body weight in kg) serum creatinine (mg/dL) x 72.0 For women, the value will be multiplied by 0.85
• MDRD formula: GFR = 170 x \[SCr\]-0.999 x \[Age\]-0.167 x \[0.762 if subject is female\] x \[1.180 if subject is black\] x \[sun\] -0.170SAlb\]-0.318
• mean Hgb \< 11 g/dL during the screening/baseline period (if subject is not already receiving rHuEPO therapy)
• for subjects currently receiving rHuEPO therapy, the subject must have: a stable rHuEPO dose for the past month; and a rHuEPO frequency of once weekly.
• white blood cell and platelet counts within normal limits
• serum vitamin B12 and folate levels above the lower limit of normal range
• transferrin saturation (TSAT) ≥ 20% during the screening period
• availability for follow-up assessments
• subject must be able to comprehend and be willing to, or have legally accepted representative, give written informed consent for participation in the study

You may not qualify if:

• scheduled to initiate dialysis
• uncontrolled hypertension (diastolic blood pressure \> 105 mm Hg or systolic blood pressure of \> 180 mm Hg during the screening/baseline period on two separate measurements)
• clinically unstable in the judgment of the investigator (eg, subject is in the intensive care unit, immediately post-myocardial infarction, etc)
• scheduled to receive a living donor kidney transplant
• treatment of grand mal epilepsy within the past 6 months
• moderate to severe congestive heart failure (NYHA class III or IV)
• clinical evidence of severe secondary hyperparathyroidism (parathyroid hormone level \> 1500 pg/mL)
• severe active chronic inflammatory process (eg, ulcerative colitis, peptic ulcer disease, rheumatoid arthritis, etc)
• currently receiving antibiotic therapy for systemic infection (enrollment may be postponed until the course of antibiotics has ended)
• known aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of the normal range on more than one occasion within three months prior to screening
• known positive HIV antibody or hepatitis B surface antigen
• clinical evidence of current malignancy and/or receiving chemotherapy with the exception of basal cell or squamous cell carcinoma of the skin and cervical intraepithelial neoplasia
• active bleeding or RBC transfusion within eight weeks of enrollment
• androgen therapy within four weeks before enrollment
• known hematologic disease (eg, sickle cell anemia, myelodysplastic syndromes, hematologic malignancy, myeloma; hemolytic anemia, etc)

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Abu-Alfa AK, Sloan L, Charytan C, Sekkarie M, Scarlata D, Globe D, Audhya P. The association of darbepoetin alfa with hemoglobin and health-related quality of life in patients with chronic kidney disease not receiving dialysis. Curr Med Res Opin. 2008 Apr;24(4):1091-100. doi: 10.1185/030079908x280653. Epub 2008 Mar 6.

  PMID: 18328118 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases; Anemia

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; 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; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 24, 2006
• First Posted: August 29, 2006
• Study Start: January 1, 2002
• Primary Completion: March 1, 2004
• Study Completion: May 1, 2004
• Last Updated: March 5, 2010

Record last verified: 2010-03