Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction (RIPE)

This study is currently recruiting participants.
Verified October 2013 by Peking University First Hospital
Sponsor:
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01580046
First received: April 16, 2012
Last updated: October 14, 2013
Last verified: October 2013

April 16, 2012
October 14, 2013
April 2012
December 2013   (final data collection date for primary outcome measure)
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01580046 on ClinicalTrials.gov Archive Site
  • In each group(Iodixanol group and Iopromide group), the proportion of patients exhibiting an increases of serum creatinine in different range(<10%,10%~25%, and ≥25%), comparing with baseline level. [ Time Frame: days 3 and 7 ] [ Designated as safety issue: No ]
  • Incidence of hemodialysis [ Time Frame: days 3 and 7 ] [ Designated as safety issue: Yes ]
  • Changes of Cystatin C level from baseline [ Time Frame: days 1 and 3 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction
Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial

The purpose of this study is to compare renal toxicity of Iodixanol and Iopromide in patients with renal dysfunction.

The study is designed to compare renal toxicity of Iodixanol and Iopromide after coronary angiography or percutaneous coronary intervention (PCI) in patient with Chronic Kidney Disease, considering original renal function and adequate hydration. The risk of varying degree of renal impairment, changes of serum Cys C level will also be evaluated.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Kidney Failure, Chronic
  • Drug: iodixanol
    1. coronary angiography, 32gI/100ml, 40~60 ml once injection
    2. left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30~60 ml once injection
  • Drug: iopromide
    coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8 ml once injection
    Other Name: Ultravist
  • Experimental: Iodixanol
    Intervention: Drug: iodixanol
  • Active Comparator: iopromide
    Intervention: Drug: iopromide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provides written Informed Consent and is willing to comply with protocol requirements
  • Is referred for cardiac angiography, with or without PCI
  • Has a documented predose serum creatinine level of 1.5~3.5 mg/dl for men and 1.3~3.0 mg/dl for women
  • Serum creatinine levels of twice tests conform with the baseline criteria, and the difference of twice serum creatinine tests is not more than 30%(first test: within 3 month,prior to enrollment; second test: at enrollment)

Exclusion Criteria:

  • Has a history of hypersensitivity to iodine-containing compounds
  • Has end-stage renal disease
  • Has kidney transplantation
  • Has creatinine clearance rates >60 ml/min in last 3 months
  • Has acute coronary syndrome with heart failure(above class II in accordance with Killip or class III in accordance with the classification of the New York Heart Association (NYHA)) and shock
  • Patients with cancer
  • Has diabetes with serious complications, other kidney organs
  • Patients with serious blood system disease
  • Heart failure [class III~Ⅳ in accordance with the classification of the New York Heart Association (NYHA) and (or) pulmonary edema]
  • Patients with hepatic insufficiency[3 times as ALT and (or) AST normal reference value limit]
  • Has received an iodinated contrast agent within 14 days prior to the administration of the study agent
  • Is scheduled to receive an iodinated contrast agent within 7 days after administration of the study agent
  • Has acute renal failure or end-stage renal disease requiring dialysis in the past 3 months
  • Use of 3 days continuously nonsteroidal anti-inflammatory drugs within 1 week of the procedure
  • Patients with hypotension [(SBP<80 mmHg for over 1h and needing Medication or intraaortic balloon counterpulsation(IABP) ]
  • Uncontrolled condition of hyperthyroidism
  • pregnancy or lactation
  • Is planned to receive the drugs without permission in this protocol
  • Participating in another intervention research study in last 3 months
  • legally incapacitated or limitations
  • Any other conditions not suitable to be enrollment
Both
18 Years to 75 Years
No
Contact: Zhaoping Liu, MD 86-10-83575727 dr_liuzhp@yahoo.com.cn
China
 
NCT01580046
XNK201201
No
Yong Huo, Peking University First Hospital
Yong Huo
Not Provided
Not Provided
Peking University First Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP