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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01580046
Recruitment Status : Unknown
Verified October 2013 by Yong Huo, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : April 18, 2012
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Yong Huo, Peking University First Hospital

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

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: iodixanol Drug: iopromide Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Renal Toxicity of Iodixanol and Iopromide in Patients With Renal Dysfunction—a Multicentre, Single Blind, Randomized Controlled, Prospective Trial
Study Start Date : April 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Iodixanol 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

Active Comparator: iopromide Drug: iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5~8 ml once injection
Other Name: Ultravist




Primary Outcome Measures :
  1. to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate [ Time Frame: days 3 and 7 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence of hemodialysis [ Time Frame: days 3 and 7 ]
  3. Changes of Cystatin C level from baseline [ Time Frame: days 1 and 3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01580046


Contacts
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Contact: Zhaoping Liu, MD 86-10-83575727 dr_liuzhp@yahoo.com.cn

Locations
Show Show 19 study locations
Sponsors and Collaborators
Yong Huo

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Responsible Party: Yong Huo, MD, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01580046    
Other Study ID Numbers: XNK201201
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Yong Huo, Peking University First Hospital:
Chronic Kidney Disease
Coronary Angiography
Contrast Media
Percutaneous Coronary Intervention
Serum Creatinine
Glomerular Filtration Rate
Iodixanol
Iopromide
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Triiodobenzoic Acids
Plant Growth Regulators
Growth Substances
Physiological Effects of Drugs