Status:
COMPLETED
Correction of Anaemia and Progression of Renal Failure on Transplanted Patients
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Anaemia
Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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...
Detailed Description
The number of patients arriving each year at the stage of final renal insufficiency (IRT) and requiring the dialysis of substitution does not cease growing, in parallel with continuous ageing of the p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00396435
Start Date
April 1 2004
End Date
May 1 2010
Last Update
September 23 2025
Active Locations (20)
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1
Hôpital Sud
Amiens, France, 80000
2
Hôpital de Bois Guillaume
Bois-Guillaume, France, 76230
3
Hôpital Pellegrin
Bordeaux, France, 33076
4
Hôpital Clémenceau
Caen, France, 14033