Clinical trial NCT00109291 (phase 2, status: terminated)
Conditions: anemia, chronic kidney disease, chronic renal failure
ICD codes: D53.2, D64.9, D46.4, D53.0, D53.9, D61.3, D61.9, I12.9, N18.9, I12.0, D63.1, N18.1, N18.5, I13.0, I13.11, I13.2
Drugs: placebo, peginesatide
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    due to slow enrollment
  
Eligibility criteria:

        Inclusion Criteria:

          1. Participant is informed of the investigational nature of this study and has given
             written, witnessed informed consent in accordance with institutional, local, and
             national guidelines;

          2. Males or females ≥ 18 and ≤ 75 years of age. Pre-menopausal females (with the
             exception of those who are surgically sterile) must have a negative pregnancy test at
             screening; those who are sexually active must practice an adequate form of
             contraception for at least 2 weeks prior to study start, and must be willing to
             continue contraception for at least 4 weeks after receiving study drug;

          3. Chronic kidney disease stage 3 or 4 (glomerular filtration rate [GFR] of 15-60
             milliliter per minute (mL/min) within 28 days prior to administration of study drug,)
             not requiring dialysis;

          4. Two hemoglobin values of ≥ 9 grams per deciliter (g/dL) and ≤ 11 g/dL within 14 days
             prior to administration of study drug, with one of the values drawn within 7 days
             prior to administration of study drug;

          5. One serum ferritin level ≥ 100 micrograms per liter (µg/L) and one transferrin
             saturation ≥ 20% within 28 days prior to administration of study drug;

          6. One serum folate level above the lower limit of normal within 28 days prior to
             administration of study drug;

          7. One vitamin B12 level above the lower limit of normal within 28 days prior to
             administration of study drug;

          8. Weight ≥ 45 kg within 28 days prior to administration of study drug;

          9. One white blood cell count ≥ 3.0 x 10^9/L within 28 days prior to administration of
             study drug; and

         10. One platelet count ≥ 140 x 10^9/L and ≤ 500 x 10^9/L within 28 days prior to
             administration of study drug.

        Exclusion Criteria:

          1. Prior treatment with any erythropoiesis stimulating agent;

          2. History of pure red cell aplasia;

          3. Red blood cell transfusion within 3 months prior to study drug administration;

          4. Hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types,
             etc.);

          5. Hemolysis based on medical judgment;

          6. Chronic, uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid
             arthritis, systemic lupus erythematosus, etc.);

          7. C Reactive Protein (CRP) greater than 30 mg/L within 14 days prior to administration
             of study drug;

          8. Significant infection within 4 weeks prior to study drug administration, per
             Investigator's clinical judgment ;

          9. Febrile illness within 7 days prior to administration of study drug;

         10. Uncontrolled or symptomatic secondary hyperparathyroidism;

         11. Poorly controlled hypertension within 4 weeks prior to study drug administration, per
             Investigator's clinical judgment (e.g. systolic ≥ 170mm Hg, diastolic ≥ 100 mm Hg on
             repeat readings);

         12. Epileptic seizure in the 6 months prior to study drug administration;

         13. Chronic congestive heart failure (New York Heart Association Class IV);

         14. High likelihood of early withdrawal or interruption of the study (e.g., myocardial
             infarction, severe or unstable coronary artery disease, stroke, respiratory,
             autoimmune, neuropsychiatric, or neurological abnormalities, liver disease including
             active hepatitis B or C, active HIV disease, or any other clinically significant
             medical diseases or conditions within the past 6 months that may, in the
             Investigator's opinion, interfere with assessment or follow-up of the patient);

         15. Malignancy (except non-melanoma skin cancer);

         16. Life expectancy < 12 months;

         17. Anticipated elective surgery during the study period;

         18. Previous exposure to any investigational agent within 4 months prior to administration
             of study drug or planned receipt during the study period.