Double-Blind Placebo-Controlled CIN Trial

NCT02467075 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: HUM 00097944
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.

Conditions

Acute Kidney Injury

Keywords

CT, iodinated contrast, contrast-induced AKI, kidney injury

Outcome Measures

Primary Outcomes (1)

• Participants With Stage II AKI (Acute Kidney Injury)

  Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.

  48 hours

Secondary Outcomes (5)

• Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition

  48-72 hours

• Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)

  30 days

• Hospital Length of Stay

  Duration of hospital stay (assessed from date of randomization up to 30 days)

• 30-day Readmission

  30 days

• Mortality Rate - 30 Day

  30 days

Study Arms (2)

Iopamidol 300 (Contrast)

ACTIVE COMPARATOR

Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.

Drug: Iopamidol 300 (Contrast)

Placebo (Normal Saline)

PLACEBO COMPARATOR

Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT.

Drug: Placebo (Normal Saline)

Interventions

Iopamidol 300 (Contrast) DRUG

Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan

Iopamidol 300 (Contrast)

Placebo (Normal Saline) DRUG

Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan

Also known as: Normal saline

Placebo (Normal Saline)

Eligibility Criteria

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

You may qualify if:

• Inpatients scheduled for CT scan of abdomen and/or pelvis
• Had surgery in the last 4 weeks
• Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT)
• Suspected infection or fluid collection in abdomen and/or pelvis

You may not qualify if:

• Pregnant
• Severe Allergy (anaphylaxis) to contrast
• Dialysis in last 7 days
• Received intravascular iodinated contrast in last 48 hours
• CT of abdomen and pelvis in last 7 days shows no fluid collection
• Prisoners
• CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast

Sponsors & Collaborators

• University of Michigan: lead
• Radiological Society of North America: collaborator

Study Sites (1)

University of Michigan Hospital Department of Radiology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Contrast Media; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

The decision to terminate the study due to low accrual potential was made in February 2016, but last data collection from the 1 subject was in September 2015.

Results Point of Contact

• Title: Matthew Davenport, MD
• Organization: University of Michigan, Department of Radiology

matdaven@med.umich.edu

734-232-2095

Study Officials

• Matthew Davenport, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: June 9, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)