- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00476619
Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial (ERIN)
Full Title: A Randomized Controlled Trial of Procrit for the Prevention of Acute Renal Failure in Patients Receiving Intravenous Contrast
Primary Objective: To evaluate the efficacy of a one-time dose of intravenous erythropoietin administration in the prevention or attenuation of contrast-induced acute renal failure.
Secondary Objectives: To evaluate serum and urinary markers of renal injury, including KIM-1, BMP-7, and TGF-b, along with other biomarkers, in subjects receiving intravenous contrast and correlate their expression with clinical outcomes
Study Design: Prospective, multi-centered, randomized, double blind, placebo controlled trial of a one-time dose of EPO. Subjects will be followed for seven days or until hospital discharge, whichever is longer. Total estimated study duration 3 years.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Adult subjects with or without diabetes mellitus Eligibility Criteria: undergoing intravenous contrast administration for computerized axial tomography (CAT Scan) as inpatients.
Subjects will be excluded if they have end-stage renal disease (on dialysis or peritoneal dialysis); any known history of acute renal failure; have hemoglobin ³ 12.0 g/dL; history of use of erythropoietin replacement or transfusion within the prior 3 days; use Glucophage/Metformin or Glucovance; are unable to give their written informed consent; have hemodynamic instability; have uncontrolled hypertension; have any history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease; any history of MI, CVA, active angina or unstable angina within the past three months ; are pregnant or lactating; allergic to intravenous contrast, iodine, erythropoietin, mammalian-cell derived products, or human albumin; patients with seizure disorders or have CT scan done as hospital outpatients.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Womens Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Subjects age 18 and over and of either gender.
- Scheduled to receive CT scan with intravenous contrast dye.
- Non diabetics or subjects with type 1 or 2 diabetes mellitus
- Written informed consent.
- Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.
- Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded
Exclusion Criteria:
- Pregnant or lactating women.
- End-stage renal disease (on hemodialysis or peritoneal dialysis)
- A known history of acute renal failure
- Subjects receiving glucophage/metformin or glucovance
- Subjects who cannot give written informed consent.
- Subjects receiving peritoneal dialysis or hemodialysis.
- Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.
- Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.
- Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.
- Age < 18 years
- Use of any erythropoietin replacement or transfusion within the prior 3 days
- Baseline Hemoglobin > 12.0 g/dL
- Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours.
- Evidence of hemodynamic instability
- Subject unable to follow protocol due to mental incompetence or other reason
- Inaccessibility of medical record
- Subjects with a history of MI, CVA, active angina or unstable angina within the past three months
- Subjects with a history of current malignancy, where current malignancy is defined as subjects undergoing treatment with chemotherapy or radiation therapy, subjects with known metastatic disease, and those with terminal malignant disease.
- Subject with any known history of seizure disorders
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: Erythropoeitin
Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
|
Subjects will receive a one-time dose of either placebo, or EPO 40,000 U intravenously 30 to 240 minutes prior to intravenous contrast administration.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo
Tidsram: 7 days
|
7 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Doubling of serum creatinine 2) Need for dialytic support 3) Patient death 4) Comparison of urinary markers of renal injury in subjects in study group vs. placebo and in subjects with and without ARF
Tidsram: 7 days
|
7 days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ajay K Singh, M.D., Brigham and Womens Hospital and Harvard Medical School
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2004P000510
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Kontrastinducerad nefropati
-
EgymedicalpediaAvslutadKoppar Intrauterin Device Induced BlödningEgypten
-
SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark
-
The University of The West IndiesCaribbean Health Research CouncilOkändMikroalbuminuri | Sickle Cell NephropathyJamaica
-
Centre for the Rehabilitation of the Paralysed,...Midwestern University; Jahangirnagar University, Bangladesh; University of...AvslutadSvaghet i extremiteter som följd av stroke | Modified Constraint Induced Movement Therapy efter stroke | Övre extremitet Funktionell prestanda efter strokeBangladesh
-
University of AarhusAktiv, inte rekryterandeNefrotiskt syndrom | Minimal förändringssjukdomDanmark
-
Arcispedale Santa Maria Nuova-IRCCSOkändMultipelt myelom | Akut njurskada | Cast NephropathyItalien
-
University Hospital BirminghamOrtho Biotech, Inc.; Gambro Renal Products, Inc.AvslutadMultipelt myelom | Njursvikt | Cast NephropathyStorbritannien
-
University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)AvslutadSicklecellanemi | Sickle Cell NephropathyFörenta staterna
-
University of Illinois at ChicagoGlobal Blood TherapeuticsRekryteringSicklecellanemi | Sickle Cell NephropathyFörenta staterna
Kliniska prövningar på erythropoeitin
-
SandozHexal AGAvslutad