Correction of Anaemia and Progression of Renal Failure on Transplanted Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00396435
• Date of registration: 03/11/2006
• Prospective Registration: No
• Primary sponsor: Centre Hospitalier Universitaire, Amiens
• Public title: Correction of Anaemia and Progression of Renal Failure on Transplanted Patients
• Scientific title: Multicenter, Prospective, Randomised, Open-label Study, Evaluating the Effect of Two Levels of Haemoglobin on Quality of Life and Speed of Progression of Renal Insufficiency on Renal Transplanted Patients With Chronic Graft Dysfunction (CGD)
• Date of first enrolment: April 2004
• Target sample size: 128
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00396435
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

France

Contacts

• Name: Franck Martinez, MD, PhD
• Affiliation: Hôpital Necker- Enfants Malades - PARIS

• Name: Gabriel Choukroun, MD, PhD
• Affiliation: CHU Amiens

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Kidney Failure

Renal Transplantation

Anaemia

Intervention(s)

Drug: Neorecormon

Primary Outcome(s)

eClcr by Cockcroft formula [Time Frame: 2 years]

Secondary Outcome(s)

Number of units of beta-EPO managed in the 2 groups [Time Frame: 2 years]

Measure CDG by the clearance of Iohexol [Time Frame: 2 years]

1/Scr at J0, 6 months, 12 months, 18 months and 24 months Scr with J0, 6, 12, 18 and 24 months [Time Frame: 2 years]

Biological tolerance: Albuminemia, pre-albuminemia, CRP, plasmatic Cholesterol, HDL and LDL [Time Frame: 2 years]

Evaluation of the quality of life in the 2 groups of patients per self-evaluation at J0 and 6 months [Time Frame: 6 months]

Level of blood pressure at the beginning and the end of the study and comparison of the number of antihypertensive drugs received by patients before and after the 24 months of follow-up [Time Frame: 2 years]

Adverse events, in particular cardiovascular events: MI, AIT, Arteritis of lower limb, revascularisation, [Time Frame: 2 years]

Proteinuria and micro-albuminuria at J0, 12 and 24 months [Time Frame: 2 years]

Number of patients receiving blood transfusions [Time Frame: 2 years]

Secondary ID(s)

CAPRIT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Roche Pharma AG