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Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial (ERIN)

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ClinicalTrials.gov Identifier: NCT00476619
Recruitment Status : Terminated (The exclusion criteria were stringent and enrollment was slow.)
First Posted : May 22, 2007
Last Update Posted : April 6, 2009
Sponsor:
Collaborator:
Ortho Biotech Products, L.P.
Information provided by:
Brigham and Women's Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Contrast Induced Nephropathy Drug: erythropoeitin Phase 4

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial
Study Start Date : September 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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.
 Drug: 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.
Other Name: PROCRIT


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects age 18 and over and of either gender.
  2. Scheduled to receive CT scan with intravenous contrast dye.
  3. Non diabetics or subjects with type 1 or 2 diabetes mellitus
  4. Written informed consent.
  5. Subjects who are on diuretics and non-steroidal inflammatory agents will not be excluded.
  6. Subjects who have received n-acetylcysteine or sodium bicarbonate pre CT scan will not be excluded

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. End-stage renal disease (on hemodialysis or peritoneal dialysis)
  3. A known history of acute renal failure
  4. Subjects receiving glucophage/metformin or glucovance
  5. Subjects who cannot give written informed consent.
  6. Subjects receiving peritoneal dialysis or hemodialysis.
  7. Subjects enrolled in another investigational drug study ≤ 30 days of enrollment into the present study.
  8. Subjects with a known hypersensitivity or anaphylaxis to contrast dye or iodine.
  9. Subjects with known hypersensitivity or anaphylaxis to erythropoietin, mammalian-cell derived products, or human albumin.
  10. Age < 18 years
  11. Use of any erythropoietin replacement or transfusion within the prior 3 days
  12. Baseline Hemoglobin > 12.0 g/dL
  13. Uncontrolled hypertension, systolic BP > 180 mmHg or diastolic BP > 110 mmHg in any recording in the past 24 hours.
  14. Evidence of hemodynamic instability
  15. Subject unable to follow protocol due to mental incompetence or other reason
  16. Inaccessibility of medical record
  17. Subjects with a history of MI, CVA, active angina or unstable angina within the past three months
  18. 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.
  19. Subject with any known history of seizure disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476619


Locations
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United States, Massachusetts
Brigham and Womens hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Ortho Biotech Products, L.P.
Investigators
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Principal Investigator: Ajay K Singh, M.D. Brigham and Womens Hospital and Harvard Medical School
More Information
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Responsible Party: Dr Ajay K Singh, MD MBA FRCP, Brigham and Womens Hospital
ClinicalTrials.gov Identifier: NCT00476619    
Other Study ID Numbers: 2004P000510
First Posted: May 22, 2007    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009
Keywords provided by Brigham and Women's Hospital:
Contrast
Nephropathy
acute renal failure
Erythropoietin
CT scan
Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics