Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT00396435
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00396435
Study Brief:
Protocol Section:
NCT00396435