Correction of Anaemia and Progression of Renal Failure on Transplanted Patients - Full Text View

Sponsors and Collaborators:	Centre Hospitalier Universitaire, Amiens Hoffmann-La Roche
Information provided by:	Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:	NCT00396435

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 IV

MedlinePlus related topics: Anemia Kidney Failure Kidney Transplantation Methamphetamine

Drug Information available for: Epoetin beta Amphetamine Methamphetamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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)

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

Primary Outcome Measures:

eClcr by Cockcroft formula [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measure CDG by the clearance of Iohexol [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Proteinuria and micro-albuminuria at J0, 12 and 24 months [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Evaluation of the quality of life in the 2 groups of patients per self-evaluation at J0 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Adverse events, in particular cardiovascular events: MI, AIT, Arteritis of lower limb, revascularisation, [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Biological tolerance: Albuminemia, pre-albuminemia, CRP, plasmatic Cholesterol, HDL and LDL [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Number of units of beta-EPO managed in the 2 groups [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of patients receiving blood transfusions [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	128
Study Start Date:	April 2004
Estimated Study Completion Date:	March 2009
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group A: Experimental 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
Group B: Active Comparator 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

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

Contacts

Contact: Gabriel Choukroun, MD, PhD	+33 (0)3 22 45 58 62	choukroun.gabriel@chu-amiens.fr
Contact: Christine Lebel, CRA	+33(0)3 22 66 78 77	lebel.christine@chu-amiens.fr

Locations

France
Hôpital Sud	Recruiting
Amiens, France, 80000
Contact: Gabriel Choukroun, MD, PhD +33 (0)3 22 45 58 62 choukroun.gabriel@chu-amiens.fr
Contact: Christine Lebel, CRA +33(0)3 22 66 78 77 lebel.christine@chu-amiens.fr
Principal Investigator: Gabriel Choukroun, MD, PhD
Sub-Investigator: Pierre-François Westeel, MD
Sub-Investigator: Hakim Mazouz, MD
Sub-Investigator: Claire Presne, MD
Hôpital Necker - Enfants Malades	Recruiting
Paris, France, 75743
Contact: Franck Martinez, MD, PhD +33 (0)1 44 49 53 06 frank.martinez@nck.ap-hop-paris.fr
Contact: Sophie Lechaton, nurse sophie.lechaton@nck.ap-hop-paris.fr
Principal Investigator: Franck Martinez, MD, PhD
Sub-Investigator: Christophe Legendre, MD
Sub-Investigator: Eric Thervet, MD
Sub-Investigator: Fabien Metivier, MD
Sub-Investigator: Evangeline Pillebout, MD
Sub-Investigator: Leila Tricot, MD
Sub-Investigator: Linda Bererhi, MD
Sub-Investigator: Salima Saksi, MD
Hôpital Maison Blanche	Recruiting
Reims, France, 51092
Contact: Olivier Toupance, MD +33 (0)3 26 78 76 36 otoupance@chu-reims.fr
Principal Investigator: Olivier Toupance, MD
Hôpital Dupuytren	Recruiting
Limoges, France, 87052
Contact: Yann Lemeur, MD 05 55 05 80 13 yann.lemeur@chu-limoges.fr
Principal Investigator: Yann Lemeur, MD
Sub-Investigator: Jean-Philippe Rerolle, MD
Sub-Investigator: Jean-Christophe Szelag, MD
Hôpital de la Milétrie	Recruiting
Poitiers, France, 86021
Contact: Guy Touchard, MD +33 (0)5 49 44 42 37 g.touchard@chu-poitiers.fr
Sub-Investigator: Antoine Thierry, MD
Principal Investigator: Guy Touchard, MD
Hôpital de Bois Guillaume	Recruiting
Bois-Guillaume, France, 76230
Contact: Michel Godin, MD +33(0)2 32 88 90 53 michel.godin@chu-rouen.fr
Sub-Investigator: Isabelle Etienne, MD
Principal Investigator: Michel Godin, MD
CHU de Tours - Hôpital Bretonneau	Recruiting
Tours, France, 37044
Contact: Yvon Lebranchu, MD +33 (0)2 47 47 82 29 lebranchu@med.univ-tours.fr
Sub-Investigator: Matthias Buchler, MD
Sub-Investigator: Jean-Michel Halimi, MD
Sub-Investigator: Azmi Al Najjar, MD
Principal Investigator: Yvon Lebranchu, MD
CHU Clermont Ferrand - Hôpital Gabriel Monpied	Recruiting
Clermont Ferrand, France, 63003
Contact: Patrice Deteix, MD +33 (0)4 73 75 14 25 pdeteix@chu-clermontferrand.fr
Principal Investigator: Patrice Deteix, MD
Sub-Investigator: Anne Elisabeth Heng, MD
Hôpital Civil	Recruiting
Strasbourg, France, 67091
Contact: Bruno Moulin, MD +33 (0)3 88 11 62 96 Bruno.Moulin@nephro.u-strasbg.fr
Principal Investigator: Bruno Moulin, MD
Sub-Investigator: Françoise Heibel, MD
Hôpital Pontchaillou	Recruiting
Rennes, France, 35033
Contact: Patrick Le Pogamp, MD +33 (0)2 99 28 43 96 patrick.le.pogamp@chu-rennes.fr
Principal Investigator: Patrick Le Pogamp, MD
Hôpital de la Tronche	Recruiting
Grenoble, France, 38043
Contact: Philippe Zaoui, MD +33 (0)4 76 76 55 23 pzaoui@chu-grenoble.fr
Principal Investigator: Philippe Zaoui, MD
Sub-Investigator: François Bayle, MD
Sub-Investigator: Bénédicte Janbon, MD
Hôpital Calmette	Recruiting
Lille, France, 59037
Contact: Christian Noel, MD +33 (0)3 20 44 41 42 cnoel@chru-lille.fr
Sub-Investigator: François-Xavier Glowacki, MD
Sub-Investigator: Marc Hazzan, MD
Sub-Investigator: François Provot, MD
Hôpital Rangueil	Recruiting
Toulouse, France, 33076
Contact: Dominique Durand, MD +33 (0)5 61 32 26 71 durand.d@chu-toulouse.fr
Principal Investigator: Dominique Durand, MD
Sub-Investigator: Lionel Rostaing, MD
Hôpital Pellegrin	Recruiting
Bordeaux, France, 33076
Contact: Pierre Merville, MD +33 (0)5 56 79 55 38 pierre.merville@chu-bordeaux.fr
Principal Investigator: Pierre Merville, MD
Sub-Investigator: Delphine Morel, MD
Sub-Investigator: Karine Moreau, MD
Sub-Investigator: Lionel Couzi, MD
Hôpital Pasteur	Recruiting
Nice, France, 06002
Contact: Elisabeth Cassuto, MD +33 (0)4 92 03 79 18 cassuto-viguier.e@chu-nice.fr
Principal Investigator: Elisabeth Cassuto, MD
Hôpital Brabois	Recruiting
Vandoeuvre les Nancy, France, 54500
Contact: Michèle Kessler, MD +33 (0)3 83 15 31 63 m.kessler@chu-nancy.fr
Principal Investigator: Michèle Kessler
Hôpital de la Conception	Recruiting
Marseille, France, 13385
Contact: Bertrand Dussol, MD +33 (0)4 91 38 30 42 bertrand.dussol@ap-hm.fr
Principal Investigator: Bertrand Dussol, MD
Hôpital Clémenceau	Recruiting
Caen, France, 14033
Contact: Bruno Hurault de Ligny, MD +33 (0)2 31 27 25 75 huraultdeligny-b@chu-caen.fr
Principal Investigator: Bruno Hurault de Ligny, MD
Hôpital Foch	Recruiting
Suresnes, France, 92151
Contact: Michel Delahousse, MD +33 (0)1 46 24 21 40 michel.delahousse@hopital-foch.org
Principal Investigator: Michel Delahousse, MD
Sub-Investigator: Alexandre Karras, MD
Sub-Investigator: A Kolko, MD
Sub-Investigator: M Pastural, MD
Hôpital Henri Mondor	Recruiting
Créteil, France, 94010
Contact: Philippe Lang, MD +33 (0)1 49 81 24 52 philippe.lang@hmn.ap-hop-paris.fr
Principal Investigator: Philippe Lang, MD
Sub-Investigator: Vincent Audard, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Hoffmann-La Roche

Investigators

Principal Investigator:	Gabriel Choukroun, MD, PhD	CHU Amiens
Principal Investigator:	Franck Martinez, MD, PhD	Hôpital Necker- Enfants Malades - PARIS

More Information

Responsible Party:	CHU ( Centre Hospital-Universitaire d'Amiens )
Study ID Numbers:	CAPRIT
Study First Received:	November 3, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00396435
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee

Keywords provided by Centre Hospitalier Universitaire, Amiens:

anaemia
renal transplantation
kidney failure

Study placed in the following topic categories:

Methamphetamine
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Disease Progression

Anemia
Quality of Life
Amphetamine
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009