Erythropoietin in Radiocontrast Induced Nephropathy (ERIN) Trial

NCT00476619 | Terminated Phase 4 DMC

• 1 other identifier: 2004P000510
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Induced Nephropathy

Keywords

Contrast; Nephropathy; acute renal failure; Erythropoietin; CT scan

Outcome Measures

Primary Outcomes (1)

• Comparison of incidence of rise in serum creatinine of 25% or more in the study group vs. placebo

  7 days

Secondary Outcomes (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

  7 days

Study Arms (1)

Erythropoeitin

PLACEBO COMPARATOR

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

Interventions

erythropoeitin DRUG

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.

Also known as: PROCRIT

Erythropoeitin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Ortho Biotech Products, L.P.: collaborator

Study Sites (1)

Brigham and Womens hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

  PMID: 39301879 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Acute Kidney Injury

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ajay K Singh, M.D.

  Brigham and Womens Hospital and Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: September 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2008
• Last Updated: April 6, 2009

Record last verified: 2009-04

Locations

US (1)