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Sponsors and Collaborators: |
Centre Hospitalier Universitaire, Amiens Hoffmann-La Roche |
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Information provided by: | Centre Hospitalier Universitaire, Amiens |
ClinicalTrials.gov Identifier: | NCT00396435 |
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 |
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) |
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
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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
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Group B: Active Comparator
Low Hb Target
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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
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Gabriel Choukroun, MD, PhD | CHU Amiens |
Principal Investigator: | Franck Martinez, MD, PhD | Hôpital Necker- Enfants Malades - PARIS |
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 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee |
anaemia renal transplantation kidney failure |
Methamphetamine Renal Insufficiency Urologic Diseases Hematologic Diseases Disease Progression |
Anemia Quality of Life Amphetamine Kidney Diseases Kidney Failure |
Renal Insufficiency Urologic Diseases Hematologic Diseases |
Anemia Kidney Diseases Kidney Failure |