Correction of Anaemia and Progression of Renal Failure on Transplanted Patients
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire, Amiens
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
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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
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


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