NCT00396435

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

November 3, 2006

Last Update Submit

September 18, 2025

Conditions

AnaemiaRenal TransplantationKidney Failure

Keywords

anaemiarenal transplantationkidney failure

Outcome Measures

Primary Outcomes (1)

  • eClcr by Cockcroft formula

    2 years

Secondary Outcomes (9)

  • Measure CDG by the clearance of Iohexol

    2 years

  • 1/Scr at J0, 6 months, 12 months, 18 months and 24 months Scr with J0, 6, 12, 18 and 24 months

    2 years

  • Proteinuria and micro-albuminuria at J0, 12 and 24 months

    2 years

  • Evaluation of the quality of life in the 2 groups of patients per self-evaluation at J0 and 6 months

    6 months

  • Adverse events, in particular cardiovascular events: MI, AIT, Arteritis of lower limb, revascularisation,

    2 years

  • +4 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

High Hb target

Drug: Neorecormon

Group B

ACTIVE COMPARATOR

Low Hb Target

Drug: Neorecormon

Interventions

NeorecormonDRUG

Administration SC one a week in patients randomized in group A Administration SC if Hb below 10.5 g/dl in group B

Also known as: Epoetin
Group AGroup B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hôpital Sud

Amiens, 80000, France

Location

Hôpital de Bois Guillaume

Bois-Guillaume, 76230, France

Location

Hôpital Pellegrin

Bordeaux, 33076, France

Location

Hôpital Clémenceau

Caen, 14033, France

Location

CHU Clermont Ferrand - Hôpital Gabriel Monpied

Clermont-Ferrand, 63003, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Hôpital de la Tronche

Grenoble, 38043, France

Location

Hôpital Calmette

Lille, 59037, France

Location

Hôpital Dupuytren

Limoges, 87052, France

Location

Hôpital de la Conception

Marseille, 13385, France

Location

Hôpital Pasteur

Nice, 06002, France

Location

Hôpital Necker - Enfants Malades

Paris, 75743, France

Location

Hôpital de la Milétrie

Poitiers, 86021, France

Location

Hôpital Maison Blanche

Reims, 51092, France

Location

Hôpital Pontchaillou

Rennes, 35033, France

Location

Hôpital Civil

Strasbourg, 67091, France

Location

Hôpital Foch

Suresnes, 92151, France

Location

Hôpital Rangueil

Toulouse, 33076, France

Location

CHU de Tours - Hôpital Bretonneau

Tours, 37044, France

Location

Hôpital Brabois

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (2)

  • Choukroun G, Kamar N, Dussol B, Etienne I, Cassuto-Viguier E, Toupance O, Glowacki F, Moulin B, Lebranchu Y, Touchard G, Jaureguy M, Pallet N, Le Meur Y, Rostaing L, Martinez F; CAPRIT study Investigators. Correction of postkidney transplant anemia reduces progression of allograft nephropathy. J Am Soc Nephrol. 2012 Feb;23(2):360-8. doi: 10.1681/ASN.2011060546. Epub 2011 Dec 22.

    PMID: 22193388RESULT

  • Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.

    PMID: 36791280DERIVED

MeSH Terms

Conditions

AnemiaRenal Insufficiency

Interventions

epoetin betaErythropoietin

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Gabriel Choukroun, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

  • Franck Martinez, MD, PhD

    Hôpital Necker- Enfants Malades - PARIS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2006

First Posted

November 7, 2006

Study Start

April 1, 2004

Primary Completion

April 1, 2009

Study Completion

May 1, 2010

Last Updated

September 23, 2025

Record last verified: 2025-09

Locations

FR(20)