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Hydroxychloroquine in Cardiovascular Disease in Patients With Chronic Kidney Disease: A Proof of Concept Study

This study has been terminated.
(lack of funding)
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01537315
First received: February 10, 2012
Last updated: November 18, 2014
Last verified: November 2014
Results First Received: October 31, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Kidney Failure, Chronic
Cardiovascular Disease
Arteriosclerosis
Interventions: Drug: Hydroxychloroquine
Other: Matching 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
Matching Placebo

Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)

Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months

Hydroxychloroquine

Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)

Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)


Participant Flow:   Overall Study
    Matching Placebo     Hydroxychloroquine  
STARTED     1     7  
COMPLETED     1     7  
NOT COMPLETED     0     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
Matching Placebo

Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)

Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months

Hydroxychloroquine

Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)

Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)

Total Total of all reporting groups

Baseline Measures
    Matching Placebo     Hydroxychloroquine     Total  
Number of Participants  
[units: participants]
  1     7     8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1     4     5  
>=65 years     0     3     3  
Gender  
[units: participants]
     
Female     0     1     1  
Male     1     6     7  
Region of Enrollment  
[units: participants]
     
United States     1     7     8  



  Outcome Measures

1.  Primary:   Change From Baseline in Inflammatory Marker, Hs-C Reactive Protein, at 6 Months   [ Time Frame: Baseline and 6 months ]


  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: Dumitru Rotaru, MD, PI
Organization: University of Arkansas for Medical Sciences
phone: 501/526-6919
e-mail: drotaru@uams.edu


No publications provided


Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01537315     History of Changes
Other Study ID Numbers: 132036
Study First Received: February 10, 2012
Results First Received: October 31, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board