The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease

• Status: Completed
• Trial end date: 2003-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess whether maintaining hemoglobin (Hb) levels at normal or sub-normal levels with Epoetin Alfa can influence the health status, left ventricular mass and quality of life of early renal insufficiency subjects without additional safety concerns.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen-Cilag B.V.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients with early renal insufficiency who are not on haemodialysis

• A baseline Hb level of >7.5 mmol/l (120 g/l) but expected to decrease during the coming months. Allowed exceptions: Hb < 7,5 mmol/l (120 g/l) for a maximum of 6 months. In medical history an Hb < 7,0 mmol/l (113 g/l) is only allowed for a maximum period of 3 months and in relation to an accidental drop in Hb (f.e. caused by surgery, gastric bleeding etc.)

• Age: 18 - 73 years, given that patients >70 years are in good general condition and are expected to complete the 30 months study period

• Creatinine clearance < 40 ml/min/1.73 m2 (Cockcroft formula) or creatinin clearance < 50 ml/min/1.73 m2), given that the clearance and Hb show a downward tendency as demonstrated in the patient files and medical history

Exclusion Criteria:

• Presence of clinically significant disease/dysfunction of hepatic, pulmonary, hematological (e.g. sickle cell anaemia, thalassemia, major myelodysplastic syndromes, hemolytic anaemia), neurological, musculo-skeletal, endocrine, gastrointestinal or genitourinary system unrelated to underlying chronic renal failure which in the opinion of the investigator would disqualify the patient from this study

• Cystic kidney disease

• Clinical or laboratory evidence of untreated iron, folate or Vitamin B12 deficiency

• Presence of concomitant malignancy (other than basal cell carcinoma of the skin)

• Uncontrolled hypertension (i.e. diastolic blood pressure of > 100 mm Hg)

• History of seizures

• Administration of medication known to suppress erythropoiesis (e.g. cytotoxic agents, immuno-suppressive) within one month prior to enrolment. Low dose steroid therapy will be permitted

• Pregnancy or lactation

• Known hypersensitivity to Epoetin alfa or one of its components.