The Effect of Epoetin Alfa on Cardiac Function and Quality of Life in Patients With Early Renal ((Kidney) Disease
Condition: Anemia
MeSH terms: Renal Insufficiency; Anemia
Study type: Interventional
Phase: Phase 3

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.
    

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. Thus, the most severe degree of anaemia is generally found in patients with end
      stage renal disease who must be maintained on dialysis. Nevertheless, a significant number of
      early renal insufficiency patients are also seen to be anaemic.

      Most patients in Europe with end stage renal disease are maintained at an Hb level between 6
      and 8 mmol/l. According to a survey during the second European Epoetin symposium (Creta,
      1998) only 20% is maintained at Hb = 8 mmol/l, but most are maintained at values lower than 8
      mmol/l. Even about 40% was maintained at Hb = 6 mmol/l.

      A number of studies have found a relationship between left ventricular hypertrophy and
      haemoglobin in dialysis and pre-dialysis patients. Also a relation between LVH and morbidity
      and mortality has been found. For this reason it should be a suggestion to treat anaemia
      towards a higher level.

      To treat Hb to a higher level a choice can be made to correct Hb when it has dropped to a
      very low level after renal disease has reached an advanced stage or alternatively to prevent
      anaemia in an early stage of renal disease. In an analysis of the normal hematocrit trial,
      Macdougall and Ritz suggest the latter. This is the main purpose of this trial.

      Treatment with Epoetin alfa also makes patients feel better physically when their exercise
      capacity improves. During treatment with Epoetin alfa, several secondary effects may
      simultaneously influence the maximal exercise capacity after correction of the anaemia. The
      improved well-being may result in an increase in physical activity and exercise capacity can
      be further improved by such conditioning. The improved oxygen transport after correction of
      anaemia reverses the circulatory adaptation to hypoxia and most studies have shown a decrease
      in cardiac output at rest, and an increase in peripheral resistance. However, approximately
      one-third of chronic renal failure patients treated with Epoetin alfa have episodes of
      hypertension, and may require increased doses of anti-hypertensive medication.

      This prospective study will assess whether maintaining Hb levels at normal or sub-normal
      levels can influence the health status, left ventricular mass and quality of life (QoL) of
      early renal insufficiency subjects without additional safety concerns. The patients will
      receive Epoetin Alfa as subcutaneous or intravenous injections in variable dosages for a
      maximum of 42 months
    

Intervention name(s): Epoetin Alfa
Intervention type(s): Drug
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; early renal insufficiency