Who is sponsoring NCT03869983?

NCT03869983 is sponsored by CyDex Pharmaceuticals, Inc..

What drugs are being tested in NCT03869983?

Interventions in NCT03869983: Omnipaque™ (iohexol) Injection, CE-Iohexol.

What condition does NCT03869983 study?

NCT03869983 studies Contrast-induced Nephropathy, Coronary Angiography.

Is NCT03869983 still recruiting?

NCT03869983 is currently completed. Last updated 16 August 2019.

Last reviewed 2019-08-16 · How we verify

NCT03869983

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection

Completed NA Last updated 16 August 2019

What this trial tests

NA trial testing Omnipaque™ (iohexol) Injection in Contrast-induced Nephropathy in 24 participants. Completed in 15 June 2019.

Timeline

12 April 2019

Primary endpoint
15 May 2019

15 June 2019

Quick facts

Lead sponsor	CyDex Pharmaceuticals, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	prevention
Enrollment	24
Start date	12 April 2019
Primary completion	15 May 2019
Estimated completion	15 June 2019
Sites	1 location across Canada

Drugs / interventions tested

Omnipaque™ (iohexol) Injection
CE-Iohexol — full drug profile →

Conditions studied

Contrast-induced Nephropathy — all drugs for Contrast-induced Nephropathy →
Coronary Angiography — all drugs for Coronary Angiography →

Sponsor

CyDex Pharmaceuticals, Inc.

Who can join

18 and older, any sex, with Contrast-induced Nephropathy or Coronary Angiography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is designed to compare the bioavailability of the test Product(CE-Iohexol Injection) and the reference product Iohexol Injection (Omnipaque™) following intravenous injection in normal healthy volunteers. The secondary objective is to assess the safety and tolerability of the treatments administered. Captisol® is present to improve stability and to potentially reduce the risk of contrast-induced acute kidney injury(CI-AKI) associated with iohexol administration.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Contrast-induced Nephropathy

Currently open trials in the same condition.

NCT07459413 — Oral vs. Intravenous Hydration to Prevent Contrast-Associated Acute Kidney Injury in the ED · NA · recruiting
NCT06418542 — Contrast Nephropathy Associated FFA · Phase 4 · active not recruiting
NCT04606056 — Risk of Acute Kidney Injury After Intravenous Contrast Computed Tomography Scans · active not recruiting
NCT05283512 — Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanc · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03869983 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by CyDex Pharmaceuticals, Inc.
Last refreshed: 16 August 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03869983.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing