Status:
COMPLETED
The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease
Lead Sponsor:
Janssen-Cilag B.V.
Conditions:
Anemia
Eligibility:
All Genders
18-73 years
Phase:
PHASE3
Brief 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...
Detailed Description
The use of Epoetin alfa in the treatment of anaemia in chronic renal failure (CRF) patients is well accepted. The severity of anaemia in CRF patients increases with the degree of renal dysfunction. Th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00446576
Start Date
November 1 1999
End Date
April 1 2003
Last Update
February 1 2011
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