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Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01663103
First received: August 7, 2012
Last updated: August 2, 2016
Last verified: June 2016
Results First Received: April 6, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Renal Insufficiency, Chronic
Interventions: Drug: Rilonacept
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rilonacept

12 weeks of treatment with rilonacept

Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)

Placebo

Twelve weeks of treatment with placebo

Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)


Participant Flow:   Overall Study
    Rilonacept     Placebo  
STARTED     21     21  
COMPLETED     18     19  
NOT COMPLETED     3     2  
Withdrawal by Subject                 1                 2  
Adverse Event                 1                 0  
dog bite                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rilonacept

12 weeks of treatment with rilonacept

Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)

Placebo

Twelve weeks of treatment with placebo

Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)

Total Total of all reporting groups

Baseline Measures
    Rilonacept     Placebo     Total  
Number of Participants  
[units: participants]
  21     21     42  
Age  
[units: years]
Mean (Standard Deviation)
  61  (11)     65  (11)     63  (11)  
Gender  
[units: participants]
     
Female     5     5     10  
Male     16     16     32  
Race/Ethnicity, Customized  
[units: participants]
     
White     16     16     32  
Hispanic     6     6     12  
African American     5     5     10  
Etiology of CKD  
[units: participants]
     
Hypertension     12     10     22  
Type II Diabetes     10     9     19  
Type I DIabetes     1     2     3  
Autosomal Dominant Polycystic Kidney Disease     1     2     3  
Renal Cell Carcinoma     0     3     3  
Focal Segmental Glomerulosclerosis     1     0     1  
Estimated glomerular filtration rate  
[units: mL/min/1.73m^2]
Mean (Standard Deviation)
  38  (14)     38  (12)     38  (13)  



  Outcome Measures
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1.  Primary:   Change in Flow-mediated Dilation (FMD)   [ Time Frame: 3 months after start of treatment ]

2.  Secondary:   Change in Aortic Pulse-wave Velocity (aPWV)   [ Time Frame: 3 months after start of treatment ]

3.  Secondary:   Change in Contribution of Oxidative Stress to FMD   [ Time Frame: 3 months after start of treatment ]

4.  Other Pre-specified:   Change in High-sensitivity C-reactive Protein (hsCRP)   [ Time Frame: 3 months after start of treatment ]

5.  Other Pre-specified:   Change in Vascular Endothelial NADPH Oxidase Expression   [ Time Frame: 3 months after start of treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Kristen Nowak
Organization: University of Colorado Anschutz Medical Campus
phone: 303-724-4842
e-mail: Kristen.Nowak@ucdenver.edu



Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01663103     History of Changes
Other Study ID Numbers: 12-0586
Study First Received: August 7, 2012
Results First Received: April 6, 2016
Last Updated: August 2, 2016
Health Authority: United States: Institutional Review Board