Correction of Anaemia and Progression of Renal Failure on Transplanted Patients

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate, on renal transplanted patients with CGD, the effect of two levels of haemoglobin on quality of life at 6 months and the speed of progression of renal function degradation at 24 months.

This study will recruit 140 patients in 21 centers in France.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborator: Roche Pharma AG

Criteria

Inclusion Criteria:

• Adults male or female of 18 years male or female sex to 70 years

• Patients having profited from one 1st or one the 2nd transplantation

• Patients transplanted since more than 1 year and less than 20 years.

• Patients having a CDG defined by a clearance of creatinin, lower than 50 ml/mn/1,73 m2 (according to Gault and Cockcroft) and whose renal function is stable over the last 3 months (variation of Scr of less than 20% over the last 3 months)

• Patients presenting an anaemia: Hb lower than 11.5 g/dl

• No deficiency out of iron: Saturation of the transferrin > 20% and ironnemia > 50 mg/l at the time of the screening visit

• Patients having given their written consent

Exclusion Criteria:

• Major forms of drepanocytosis or thalassaemia

• Iron Deficit (CST < 20% or ferritin < 50 mg/l)

• Haemolysis (haptoglobin < 0,30 g/l)

• Severe renal insufficiency: Clcr < 20 ml/min/1,73 m2

• Severe Hyperparathyroidy (serum PTH > 800 pg/ml)

• Evolutionary chronic inflammatory Disease (CRP > 15 mg/l)

• Acute or chronic infectious disease

• Evolutionary neoplasic Disease

• Infection by the HIV and viral cirrhosis

• Recent Antecedents of MI or AIT (< 3 months)

• Severe Arteritis of the lower limbs (Stage III or IV)

• Acute Rejection requiring a treatment in the 3 previous months

• Blood Transfusion on the last 3 months

• Evolutionary GI Ulcer on the last 3 months

• Severe Arterial HyperTension not controlled by medicamentous treatment (NOT > 170 mm Hg or PAD > 100 mm Hg under treatment)

• Epilepsy of recent diagnosis

• Relevant biological value(at screening visit) : - Proteinuria > 3 g/24h

• Serum Albumin < 30 g/l

• Platelets > 600.000/µl

• Programmed heavy surgery

• Pregnancy or breast feeding

• Administration of an experimental drug in the 30 days preceding the screening visit

• Known Over-sensitiveness to Epoetin beta

• Patients under Sirolimus

• Patients under EPO at screening visit