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Correction of Anaemia and Progression of Renal Failure on Transplanted Patients

CompletedPhase 4

Sponsor: Centre Hospitalier Universitaire, Amiens

Conditions: Anaemia, Renal Transplantation, Kidney Failure

Interventions: Neorecormon

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (20)

Amiens, France
Bois-Guillaume, France
Bordeaux, France
Caen, France
Clermont-Ferrand, France
Créteil, France
Grenoble, France
Lille, France
Limoges, France
Marseille, France
Nice, France
Paris, France
Poitiers, France
Reims, France
Rennes, France
Strasbourg, France
Suresnes, France
Toulouse, France
Tours, France
Vandœuvre-lès-Nancy, France