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Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Information source: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kidney Failure

Intervention: epoetin beta (NeoRecormon Âź) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Centre Hospitalier Universitaire, Amiens

Official(s) and/or principal investigator(s):
CHOUKROUN Gabriel, Ph D, Principal Investigator, Affiliation: CHU Amiens
MARTINEZ Franck, Ph D, Principal Investigator, Affiliation: Necker Hospital

Summary

Main objective : Assessing the effect of epoetin beta on Hb rate and the glomerular filtration rate estimated 30 days after kidney transplant.

Clinical Details

Official title: Effect of Epoetin Beta on Renal Function Within 30 Days Following a Kidney Transplant

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant

Secondary outcome:

The evolution of renal function

The survival of patients and grafts

The time of onset and incidence of acute rejection proved by biopsy

The correction of anemia

The need for transfusions

The need for EPO

Quality of Life

Detailed description: French study, prospective, multicenter, open, randomized into two parallel groups: Group A: NeoRecormon ź 30000 UI: 4 injections Group B: control group without administration of the medical product Period of recruitment: 18 months Duration of participation of each patient: 90 days Total duration of the test: 21 months. Main objective : Assessing the effect of epoetin beta on the glomerular filtration rate estimated 30 days after kidney transplant. Secondary objectives: Comparing the 2 groups at all times J0 to J90:

- The evolution of renal function

- The survival of patients and grafts

- The time of onset and incidence of acute rejection proved by biopsy

- The correction of anemia

- The need for transfusions

- The need for EPO

- Quality of Life

- The safety processing

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males anf Females aged between 18 and 75

- Patients having given their written consent

- Patient determined to participate in the test and to respect the requirements

- Patient covered by a social insurance

- Patient to be kidney transplanted (from a cadaveric donor)

- Patient benefiting from the 1st or 2nd kidney transplant

- Patient formerly treated by peritoneal dialysis or hemodialysis

- Patient receiving a graft with risk of delayed graft function (score> 7 combining age

of the donor, ischemia time, receiver ethnicity and cause of death)

- Patient to receive treatment with basiliximab, mycophenolate mofetil, tacrolimus and

corticosteroid Exclusion Criteria:

- Patient Pregnant or nursing

- Patient with a disability that does not ensure the good understanding of the study

and its imperatives , or patient having dependency (alcohol, drugs)

- Patient receiving doses of epoetin beta or alpha> 30,000 IU / week or darbepoetin>

150 microg / week before transplanting

- Patient who has participated in a clinical trial in the last month or currently

included in another test

- Patient in safeguarding justice, guardianship or trusteeship

- Patient receiving a third transplant or hyper immune or who have a positive historic

cross-match

- Patient receiving a preemptive transplant

- graft from a living donor

- graft with 3 or more arteries

- Multi-Organ Transplantation

- Patient with heart failure stage> III

- Patients with unstable ischemic heart disease, or have had a major coronary event

less than 6 months, stroke or TIA <6 months or symptomatic arteritis of lower limbs stage ≄ 3

- Patients with active viral infection: hepatitis B, C (PCR + only) or HIV

- Patient with a history of anemia from erythroblastopenia

- Patient receiving anticoagulant treatment(AVK) before renal transplantation and to be

continued after transplant

- Patient with a preoperative rate Hb> 14 g / dL (before ultrafiltration)

- A patient with known hypersensitivity to the active substance or to any of the

excipients, or to benzoic acid

- Patients with poorly controlled hypertension in the weeks before transplantation

(Diastolic Blood Pressure ≄ 110 mm Hg with more than 3 antihypertensive drugs)

Locations and Contacts

Amiens hospital, Amiens 80000, France

LA CAVALE BLANCHE Hospital, Brest 29200, France

MONDOR Hospital, Creteil 94010, France

MICHALLON Hospital, Grenoble 38000, France

Kremlin BicĂȘtre Hospital, Le Kremlin BicĂȘtre 94275, France

ALBERT CALMETTE Hospital, Lille 59 000, France

CHU Nantes, Hotel-Dieu Hospital, Nantes 44093, France

CHU Nice, Pasteur Hospital, Nice 06000, France

Georges Pompidou European Hospital, Paris 75015, France

Necker Hospital, Paris 75, France

TENON Hospital, Paris 75020, France

LA MILETRIE Hospital, Poitiers 86000, France

MAISON BLANCHE Hospital, Reims 51100, France

Bois Guillaume Hospital, Rouen 76230, France

FOCH Hospital, Suresnes 92151, France

RANGUEIL Hospital, Toulouse 31000, France

BRETONNEAU Hospital, Tours 37044, France

Additional Information

Starting date: October 2007
Last updated: October 19, 2011

Page last updated: August 23, 2015

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