Renal ImpairmentPhase 1NCT00879645
Pharmacokinetic Assessment of Sodium Sulfide in Subjects With Impaired Renal Function
A Phase 1 study testing Sodium Sulfide in people with Renal Impairment, run by Mallinckrodt at 1 site in United States.
Trial summary
This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Sodium Sulfide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Mar 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For normal subjects arm (CrCL > 80 ml/min): Healthy male and female subjects age 18 to 70 years of age inclusive. Pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study.
- For renally impaired arm: Male and female - pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study. Subjects with mild, moderate and severe renal function aged between 18 to 70 years old
- Body mass index (BMI) within the range of 18 to 40 kg/m2
- Electrocardiogram (ECG) recording without clinically relevant abnormalities
- Having had no febrile or infectious disease for at least seven days prior to dosing of study drug
- Able to communicate well with the study staff and to understand and comply with the requirements of the study, understand and sign the written informed consent
Who cannot join
- High risk patients who may need an urgent dialysis during clinical conduct portion of the study (from Day -1 until last PK sampling on Day 7)
- All smokers.
- More than moderate alcohol consumption (>35 g ethanol regularly or > 2 drinks per day )
- Any history of alcohol or drug abuse
- Any active physical or psychiatric disease, acute or chronic
- Any clinically relevant history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis
Show all 11Show fewer
- Pregnant or nursing women
- Blood donation within 30 days
- Participation in any clinical study within 30 days prior to the treatment phase of this study
- Lab values outside of reference range and clinically relevant liver function tests (AST, ALT, gamma-GT)
- Positive tests for HIV antibodies, Hepatitis B-virus surface antigen (HBsAg), Anti-Hepatitis C-virus antibodies (Anti-HCV)
Trial locations and contacts
1 site in 1 country.
United States1 site
DaVita Clinical Research
Minneapolis, Minnesota, 55404
About this study
Official title: A Phase I Study to Assess the Pharmacokinetics of IK-1001 (Sodium Sulfide) in Subjects With Impaired Renal Function Following a Continuous 3-hour Intravenous Infusion
This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth cohort will be subjects with intermediate renal impairment and the third cohort will be subjects with severe renal impairment and the second cohort will consist of normal healthy subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV) infusion and will be followed over a 7 day period.
Read the detailed description
This is a Phase 1 pharmacokinetic study to assess the pharmacokinetics of IK-1001 in healthy volunteers as well as subjects with varying degrees of impaired renal function following a single intravenous infusion.
A total of 28 subjects will be enrolled into the study, including 6 normal subjects (Creatinine Clearance (CrCL) > 80 mL/min), 9 subjects with mild impairment (CrCL ≥ 50 to < 80 mL/min), 6 subjects with intermediate impairment (≥ 30 to < 50 mL/min) and 7 subjects with severe impairment (CrCL < 30 mL/min).
Mild, moderate and normal healthy subjects will receive IK-1001 as a single IV infusion for 3 hours at 1.5 mg/kg/hr. Blood, plasma, urine and exhaled air will be collected from each subject over 48 hours and at follow-up visit (Day 7), to evaluate pharmacokinetics of Hydrogen Sulfide (H2S) (exhaled air), IK-1001 (blood) and thiosulfate in plasma and urine. Severe subjects will receive IK-1001 as a single IV infusion for 3 hours at 1.0 mg/kg/hr.
For each dosing cohort, the study will consist of a screening visit (Days -28 to -1), a treatment visit (Day 0 (check-in) to Day 3), and a follow-up (exit) visit day 7 (+/- 2 days).
Study subjects will be enrolled to one of 4 cohorts and all will receive investigational product at the given dose level. The subjects will be considered to be enrolled in the study at randomization.
IK-1001 will be administered by a healthcare professional intravenously over 3 hours using an infusion pump. Dosage of IK-1001 will be administered on actual body weight basis, according to cohort assignment and using the subject's body weight determined on Day -1. After the end of the initial 3-hour study period, subjects will be observed for an additional 45 hour period before discharge from the unit.
- Conditions
- Renal Impairment
- Being tested
- Sodium Sulfide
- Keywords
- Renal Impairment, Renal Disease, Sodium Sulfide
- Medical subject headings
- Renal Insufficiency, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium SulfideDrug
Also called IK-1001
Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours
Sodium SulfideDrug
Also called IK-1001
Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium SulfideDrug
Also called IK-1001
Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
Sodium SulfideDrug
Also called IK-1001
Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
| Study group | Role | What they receive |
|---|---|---|
| Sodium Sulfide - Mild Cohort | Experimental | Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours. Receives: Drug: Sodium Sulfide |
| Sodium Sulfide - Healthy Cohort | Experimental | Healthy subjects received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours Receives: Drug: Sodium Sulfide |
| Sodium Sulfide - Moderate Cohort | Experimental | Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours Receives: Drug: Sodium Sulfide |
| Sodium Sulfide - Severe Cohort | Experimental | Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours Receives: Drug: Sodium Sulfide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thiosulfate in Plasma
Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.
Measured: 8 hours after treatment
Thiosulfate in Urine
Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection
Measured: 48 hours after treatment
Sodium Sulfide in Blood
Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.
Measured: 8 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: unable to develop a rapid \& reliable assay to detect sulfide concentrations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brahm Goldstein, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879645
- Sponsor's protocol ID
- S103
- Status last verified
- Oct 2016
- First submitted
- 9 Apr 2009
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Pharmacokinetics of IK-1001 (Sodium Sulfide) in Subjects With Impaired Renal Function Following a Continuous 3-hour Intravenous Infusion
- ClinicalTrials.gov ID
- NCT00879645
- Acronym / sponsor ID
- S103
- Conditions
- Renal Impairment
- Keywords
- Renal Impairment, Renal Disease, Sodium Sulfide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to develop a rapid \& reliable assay to detect sulfide concentrations
- Enrolment
- 28 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 4 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 study to assess the pharmacokinetics (PK) of IK-1001 (sodium sulfide) in healthy volunteers as well as in subjects with varying degrees of impaired renal function. A total of 28 subjects will be enrolled into the study over a 6 month period. There will be 4 cohorts. The first cohort will consist of subjects with mild renal impairment, the fourth cohort will be subjects with intermediate renal impairment and the third cohort will be subjects with severe renal impairment and the second cohort will consist of normal healthy subjects. All subjects will receive the study drug for 3 hours as a single intravenous (IV) infusion and will be followed over a 7 day period.
Detailed description
This is a Phase 1 pharmacokinetic study to assess the pharmacokinetics of IK-1001 in healthy volunteers as well as subjects with varying degrees of impaired renal function following a single intravenous infusion.
A total of 28 subjects will be enrolled into the study, including 6 normal subjects (Creatinine Clearance (CrCL) > 80 mL/min), 9 subjects with mild impairment (CrCL ≥ 50 to < 80 mL/min), 6 subjects with intermediate impairment (≥ 30 to < 50 mL/min) and 7 subjects with severe impairment (CrCL < 30 mL/min).
Mild, moderate and normal healthy subjects will receive IK-1001 as a single IV infusion for 3 hours at 1.5 mg/kg/hr. Blood, plasma, urine and exhaled air will be collected from each subject over 48 hours and at follow-up visit (Day 7), to evaluate pharmacokinetics of Hydrogen Sulfide (H2S) (exhaled air), IK-1001 (blood) and thiosulfate in plasma and urine. Severe subjects will receive IK-1001 as a single IV infusion for 3 hours at 1.0 mg/kg/hr.
For each dosing cohort, the study will consist of a screening visit (Days -28 to -1), a treatment visit (Day 0 (check-in) to Day 3), and a follow-up (exit) visit day 7 (+/- 2 days).
Study subjects will be enrolled to one of 4 cohorts and all will receive investigational product at the given dose level. The subjects will be considered to be enrolled in the study at randomization.
IK-1001 will be administered by a healthcare professional intravenously over 3 hours using an infusion pump. Dosage of IK-1001 will be administered on actual body weight basis, according to cohort assignment and using the subject's body weight determined on Day -1. After the end of the initial 3-hour study period, subjects will be observed for an additional 45 hour period before discharge from the unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sodium Sulfide - Mild Cohort | Experimental | Drug: Sodium SulfideMild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours. |
| Sodium Sulfide - Healthy Cohort | Experimental | Drug: Sodium SulfideHealthy subjects received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours |
| Sodium Sulfide - Moderate Cohort | Experimental | Drug: Sodium SulfideModerate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours |
| Sodium Sulfide - Severe Cohort | Experimental | Drug: Sodium SulfideSevere RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For normal subjects arm (CrCL > 80 ml/min): Healthy male and female subjects age 18 to 70 years of age inclusive. Pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study.
- For renally impaired arm: Male and female - pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study. Subjects with mild, moderate and severe renal function aged between 18 to 70 years old
- Body mass index (BMI) within the range of 18 to 40 kg/m2
- Electrocardiogram (ECG) recording without clinically relevant abnormalities
- Having had no febrile or infectious disease for at least seven days prior to dosing of study drug
Key exclusion criteria (11 listed)
- High risk patients who may need an urgent dialysis during clinical conduct portion of the study (from Day -1 until last PK sampling on Day 7)
- All smokers.
- More than moderate alcohol consumption (>35 g ethanol regularly or > 2 drinks per day )
- Any history of alcohol or drug abuse
- Any active physical or psychiatric disease, acute or chronic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium SulfideAlso: IK-1001Sodium sulfide administered intravenously at 1.5 mg/kg/hr for 3 hours | Drug | Sodium Sulfide - Mild Cohort |
| Sodium SulfideAlso: IK-1001Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours | Drug | Sodium Sulfide - Healthy Cohort |
| Sodium SulfideAlso: IK-1001Sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours | Drug | Sodium Sulfide - Moderate Cohort |
| Sodium SulfideAlso: IK-1001Sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours | Drug | Sodium Sulfide - Severe Cohort |
Primary outcome
Thiosulfate in Plasma
Time frame: 8 hours after treatment
Total concentration of thiosulfate in plasma was measured through pharmacokinetic blood sampling.
Thiosulfate in Urine
Time frame: 48 hours after treatment
Total concentration of thiosulfate in urine was measure through pharmacokinetic urine collection
Sodium Sulfide in Blood
Time frame: 8 hours after treatment
Total concentration of sodium sulfide in blood was measured through pharmacokinetic blood sampling.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brahm Goldstein, MD study director
Mallinckrodt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Sulfide in people with Renal Impairment, run by Mallinckrodt at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thiosulfate in Plasma (time frame: 8 hours after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.