Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function

This study has been completed.
Sponsor:
Information provided by:
Ikaria
ClinicalTrials.gov Identifier:
NCT00879645
First received: April 9, 2009
Last updated: November 15, 2010
Last verified: November 2010
Results First Received: October 7, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Impairment
Intervention: Drug: Sodium Sulfide

  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
Sodium Sulfide - Mild Cohort Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
Sodium Sulfide - Healthy Cohort Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium Sulfide - Moderate Cohort Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium Sulfide - Severe Cohort Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours

Participant Flow:   Overall Study
    Sodium Sulfide - Mild Cohort     Sodium Sulfide - Healthy Cohort     Sodium Sulfide - Moderate Cohort     Sodium Sulfide - Severe Cohort  
STARTED     9     6     6     7  
COMPLETED     8     6     6     7  
NOT COMPLETED     1     0     0     0  
Adverse Event                 1                 0                 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.
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Reporting Groups
  Description
Sodium Sulfide - Mild Cohort Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
Sodium Sulfide - Healthy Cohort Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium Sulfide - Moderate Cohort Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium Sulfide - Severe Cohort Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
Total Total of all reporting groups

Baseline Measures
    Sodium Sulfide - Mild Cohort     Sodium Sulfide - Healthy Cohort     Sodium Sulfide - Moderate Cohort     Sodium Sulfide - Severe Cohort     Total  
Number of Participants  
[units: participants]
  9     6     6     7     28  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     9     6     6     7     28  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 7.41     56.1  ± 14.69     60.6  ± 7.91     48.9  ± 11.96     55.3  ± 10.82  
Gender  
[units: participants]
         
Female     3     3     3     5     14  
Male     6     3     3     2     14  
Region of Enrollment  
[units: participants]
         
United States     9     6     6     7     28  



  Outcome Measures
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1.  Primary:   Thiosulfate in Plasma   [ Time Frame: 8 hours after treatment ]

2.  Primary:   Thiosulfate in Urine   [ Time Frame: 48 hours after treatment ]

3.  Primary:   Sodium Sulfide in Blood   [ Time Frame: 8 hours after treatment ]

4.  Secondary:   Vital Signs   [ Time Frame: Study duration ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Urinalysis   [ Time Frame: Baseline, Days 1, 2, and 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

6.  Secondary:   Hematology   [ Time Frame: Baseline, Days 1 and 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

7.  Secondary:   12-lead ECG   [ Time Frame: Baseline, Day 0 through 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

8.  Secondary:   Coagulation Factors   [ Time Frame: Baseline, Day 1, 2, and 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

9.  Secondary:   Biochemistry   [ Time Frame: Baseline, Days 1, 2, and 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   Creatinine Clearance   [ Time Frame: Baseline, Day 7 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   Exhaled Sulfide   [ Time Frame: Baseline through day 2 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Brahm Goldstein
Organization: Ikaria Inc
phone: 908-238-6495
e-mail: brahm.goldstein@ikaria.com


No publications provided


Responsible Party: Brahm Goldstein, MD, MCR, FAAP, FCCM, Ikaria
ClinicalTrials.gov Identifier: NCT00879645     History of Changes
Other Study ID Numbers: S103
Study First Received: April 9, 2009
Results First Received: October 7, 2010
Last Updated: November 15, 2010
Health Authority: United States: Food and Drug Administration