The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of single intravenous dose levels of Hematide in patients with chronic kidney disease (CKD) who are not on dialysis.

Condition	Treatment or Intervention	Phase
Kidney Diseases	Drug: Hematide	Phase II

Further Study Details: 

Primary Outcomes: Evaluate the safety profile of single intravenous (IV) dose levels of Hematide in CKD pre-dialysis patients
Secondary Outcomes: Evaluate the dose response relationships of a single dose of Hematide on hemoglobin, reticulocytes, and iron stores; Evaluate the PK profiles of single dose levels of Hematide administered intravenously in pre-dialysis patients; Determine the pharmacologically active dose of Hematide administered intravenously in pre-dialysis patients
Expected Total Enrollment:  54

Up to a maximum of 54 pre-dialysis patients, aged 18-75 years, with hemoglobin ≥ 9 g/dL and ≤ 11 g/dL secondary to chronic kidney disease who have not had previous treatment with ESAs and who meet eligibility criteria will be enrolled in up to 6 dose cohorts (9 patients per cohort, 7 on study drug and 2 on placebo). Patients will be followed through Day 29 or until stabilization of adverse events.

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Males or females of non-childbearing potential ≥ 18 and ≤ 75 years of age
• Chronic kidney disease stage 3 or 4 not requiring dialysis
• Two hemoglobin values of ≥ 9 g/dL and ≤ 11 g/dL
• One serum ferritin level ≥ 100 µg/L and one transferrin saturation ≥ 20%
• One normal serum folate level
• One normal vitamin B12 level
• Weight ≥ 45 and ≤ 100 kg
• One white blood cell count ≥ 3.0 x 10^9/L
• One platelet count ≥ 140 x 10^9/L and ≤ 500 x 10^9/L

Exclusion Criteria:

• Prior treatment with any erythropoiesis stimulating agent
• History of pure red cell aplasia
• RBC transfusion within 3 months prior to study drug administration
• Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
• Hemolysis
• Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
• C Reactive Protein (CRP) greater than 30 mg/L
• Acute or chronic infection requiring oral or parenteral antibiotics or antivirals
• Febrile illness
• Uncontrolled or symptomatic secondary hyperparathyroidism
• Poorly controlled hypertension
• Epileptic seizure
• Chronic congestive heart failure (New York Heart Association Class IV)
• Malignancy (except non-melanoma skin cancer)
• Life expectancy < 12 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00109291

United Kingdom, London
      Parexel CPRU, Harrow,  London,  HA1 3UJ,  United Kingdom; Recruiting

Study chairs or principal investigators

Anne-Marie Duliege, MD, MS,  Study Chair,  Affymax, Inc   
Julie Iwashita,  Study Director,  Affymax, Inc   

Study ID Numbers:  AFX01-02
Record last reviewed:  April 2005
Last Updated:  April 26, 2005
Record first received:  April 26, 2005
ClinicalTrials.gov Identifier:  NCT00109291
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-05-03