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

October 14, 2013 updated by: Yong Huo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100044
        • Not yet recruiting
        • Peking University People's Hospital
        • Principal Investigator:
          • Weimin Wang, MD
      • Beijing, China, 100048
        • Recruiting
        • Pla Navy General Hospital
        • Principal Investigator:
          • Tianchang Li, MD
      • Beijing, China, 100049
        • Recruiting
        • The Central Hospital of China Aerospace Corporation
        • Principal Investigator:
          • Bin Wang, MD
        • Sub-Investigator:
          • Tao Qu, MD
        • Sub-Investigator:
          • Ying Shen, MD
      • Beijing, China, 100853
        • Not yet recruiting
        • Chinese PLA General Hospital
        • Principal Investigator:
          • Yundai Chen, MD
        • Sub-Investigator:
          • Wei Dong, MD
        • Sub-Investigator:
          • Sunying Hu, MD
      • Chongqing, China, 400037
        • Not yet recruiting
        • XinQiao Hospital, Third Military Medical University
        • Principal Investigator:
          • Lan Huang, MD
        • Sub-Investigator:
          • Jun Jin, MD
        • Sub-Investigator:
          • Yun He, MD
      • Shanghai, China, 200001
        • Not yet recruiting
        • Renji Hospital ，Shanghai Jiao Tong University School Of Medicine
        • Principal Investigator:
          • Ben He, MD
      • Shanghai, China, 200030
        • Not yet recruiting
        • Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University
        • Principal Investigator:
          • Weiyi Fang, MD
      • Shanghai, China, 200080
        • Not yet recruiting
        • Shanghai First People's Hospital
        • Principal Investigator:
          • Shaowen Liu, MD
    • Anhui
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Ji Yan, MD
        • Sub-Investigator:
          • Kefu Feng, MD
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University First Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Lianglong Chen, MD
        • Sub-Investigator:
          • Xingchun Zheng, MD
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong Academy Of Medical Sciences Guangdong General Hospital
        • Sub-Investigator:
          • Yong Liu, MD
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Lang Li, MD
        • Sub-Investigator:
          • Xiaocong Zeng, MD
    • Hebei
      • Shijiazhuang, Hebei, China, 050051
        • Not yet recruiting
        • The People's Hospital Of Hebei Province
        • Principal Investigator:
          • Xiaoyong Qi, MD
        • Sub-Investigator:
          • Tianhong Wang, MD
    • Henan
      • Luoyang, Henan, China, 450000
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Principal Investigator:
          • Chuanyu Gao, MD
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital to Nanchang University
        • Sub-Investigator:
          • Yanqing Wu, MD
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Recruiting
        • The People's Hospital of Liaoning Province
        • Principal Investigator:
          • Zhanquan Li, MD
        • Sub-Investigator:
          • Yongxin Wang, MD
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Not yet recruiting
        • The Affiliated Hospital of Medical College Qingdao University
        • Principal Investigator:
          • Yi An, MD
        • Sub-Investigator:
          • Hua Yu, MD
    • Shanxi
      • Taiyuan, Shanxi, China, 030024
        • Not yet recruiting
        • Shanxi Cardiovascular Hospital
        • Principal Investigator:
          • Bao Li, MD
        • Sub-Investigator:
          • Zhongchao Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: iopromide
Drug: iopromide
coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
Other Names:
  • Ultravist
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
to evaluate the change in Glomerular Filtration Rate levels by Estimated Glomerular Filtration Rate
Time Frame: days 3 and 7
days 3 and 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
days 3 and 7
Incidence of hemodialysis
Time Frame: days 3 and 7
days 3 and 7
Changes of Cystatin C level from baseline
Time Frame: days 1 and 3
days 1 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yong Huo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • XNK201201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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