Correction of Anaemia and Progression of Renal Failure on Transplanted Patients (NCT00396435) | Clinical Trial Compass
CompletedPhase 4
Correction of Anaemia and Progression of Renal Failure on Transplanted Patients
France128 participantsStarted 2004-04
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \> …