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Correction of Anaemia and Progression of Renal Failure on Transplanted Patients

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT00396435
First received: November 3, 2006
Last updated: May 26, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Anaemia Renal Transplantation Kidney Failure Drug: Neorecormon Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • eClcr by Cockcroft formula [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • 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 ]
  • Proteinuria and micro-albuminuria at J0, 12 and 24 months [ 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 ]
  • Adverse events, in particular cardiovascular events: MI, AIT, Arteritis of lower limb, revascularisation, [ Time Frame: 2 years ]
  • Biological tolerance: Albuminemia, pre-albuminemia, CRP, plasmatic Cholesterol, HDL and LDL [ Time Frame: 2 years ]
  • 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 ]
  • Number of units of beta-EPO managed in the 2 groups [ Time Frame: 2 years ]
  • Number of patients receiving blood transfusions [ Time Frame: 2 years ]

Estimated Enrollment: 128
Study Start Date: April 2004
Study Completion Date: May 2010
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
High Hb target
Drug: Neorecormon
Administration SC one a week in patients randomized in group A Administration SC if Hb below 10.5 g/dl in group B
Other Name: Epoetin
Active Comparator: Group B
Low Hb Target
Drug: Neorecormon
Administration SC one a week in patients randomized in group A Administration SC if Hb below 10.5 g/dl in group B
Other Name: Epoetin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396435

Locations
France
Hôpital Sud
Amiens, France, 80000
Hôpital de Bois Guillaume
Bois-Guillaume, France, 76230
Hôpital Pellegrin
Bordeaux, France, 33076
Hôpital Clémenceau
Caen, France, 14033
CHU Clermont Ferrand - Hôpital Gabriel Monpied
Clermont Ferrand, France, 63003
Hôpital Henri Mondor
Créteil, France, 94010
Hôpital de la Tronche
Grenoble, France, 38043
Hôpital Calmette
Lille, France, 59037
Hôpital Dupuytren
Limoges, France, 87052
Hôpital de la Conception
Marseille, France, 13385
Hôpital Pasteur
Nice, France, 06002
Hôpital Necker - Enfants Malades
Paris, France, 75743
Hôpital de la Milétrie
Poitiers, France, 86021
Hôpital Maison Blanche
Reims, France, 51092
Hôpital Pontchaillou
Rennes, France, 35033
Hôpital Civil
Strasbourg, France, 67091
Hôpital Foch
Suresnes, France, 92151
Hôpital Rangueil
Toulouse, France, 33076
CHU de Tours - Hôpital Bretonneau
Tours, France, 37044
Hôpital Brabois
Vandoeuvre les Nancy, France, 54500
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Roche Pharma AG
Investigators
Principal Investigator: Gabriel Choukroun, MD, PhD CHU Amiens
Principal Investigator: Franck Martinez, MD, PhD Hôpital Necker- Enfants Malades - PARIS
  More Information

Responsible Party: Centre Hospital-Universitaire d'Amiens, CHU
ClinicalTrials.gov Identifier: NCT00396435     History of Changes
Other Study ID Numbers: CAPRIT
Study First Received: November 3, 2006
Last Updated: May 26, 2010

Keywords provided by Centre Hospitalier Universitaire, Amiens:
anaemia
renal transplantation
kidney failure

Additional relevant MeSH terms:
Anemia
Renal Insufficiency
Hematologic Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 17, 2017