Kidney TransplantationPhase 2NCT00531856
Safety and Tolerability Study of Inhaled Carbon Monoxide in Kidney Transplant Patients
A Phase 2 study testing Inhaled carbon monoxide in people with Kidney Transplantation, run by Mallinckrodt at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- Inhaled carbon monoxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2007to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female receiving a kidney transplant from any donor type
- BMI between 16 and 36 inclusive
- Spontaneously breathing (non-intubated) with supplemental oxygen standardized at 2 liters via nasal cannula
- Hemodynamically stable with a systolic arterial pressure > 90 mmHg and a heart rate < 120 beats/min
- Acceptable transplantation candidate as judged by medical history, physical exam, ECG, vital signs, clinical chemistry, hematology, and urinalysis
- Given written and verbal information and had the opportunity to ask questions about the study
- Signed informed consent to participate in the study
Who cannot join
- Exposure to any carbon monoxide source (e.g., fire, gas, or heavily polluted air) during the 48 hours prior to the study day
- Baseline blood level of COHb >2%
- Baseline hemoglobin (Hb) <10.0 g/dL
- Patients with significant underlying lung disease such as moderate or severe asthma, COPD, and interstitial lung disease
- Baseline oxygen saturation <95%
- Pregnancy or breastfeeding
- Participation in other clinical trial within 2 months prior to study drug treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Universtiy of CA, San Francisco
San Francisco, California, 94143
About this study
Official title: A Prospective, Multicenter, Single-blind, Placebo-controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.
The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.
Read the detailed description
The mechanisms by which carbon monoxide exerts its effects in preventing damage of the graft appear to vary among the models and organs with the common theme of carbon monoxide acting as a potent anti-inflammatory molecule. Carbon monoxide affects several intracellular signaling pathways. In addition, carbon monoxide generates increased levels of anti-inflammatory molecules.
Evaluate the safety and tolerability of three carbon monoxide dose levels consisting of a single 0.7 mg/kg dose and a single 2.0 mg/kg dose when administered post-operatively and a single 2.0 mg/kg dose, a single 3.0mg/kg dose and a 3.5 mg/kg dose when administered intra-operatively as an inhaled gas for 1 hour, by assessment of adverse events (AEs), vital signs, laboratory variables, serum carboxyhemoglobin (COHb), oxygenation, electrocardiography (ECG), and neurocognitive status in patients receiving kidney transplants.
- Conditions
- Kidney Transplantation
- Being tested
- Inhaled carbon monoxide
- Keywords
- Kidney Transplant, Carbon Monoxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled carbon monoxideDrug
0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Inhaled carbon monoxideDrug
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant
Inhaled carbon monoxideDrug
3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Inhaled Carbon MonoxideDrug
3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant
Inhaled Carbon MonoxideDrug
2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 5.97 mg/L of carbon monoxide in 30% oxygen Receives: Drug: Inhaled carbon monoxide |
| 2 | Placebo comparator | Oxygen 30% in Nitrogen Receives: Drug: Inhaled carbon monoxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of three carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants
Measured: 28 days
Secondary outcomes (1)
Characterize the pharmacokinetics of the inhaled carbon monoxide; Correlate the safety parameters to inhaled carbon monoxide and COHb levels; Assess laboratory values; Assess potential markers for the incidence of delayed graft function
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Clinical Hold pending additional data review and protocol amendment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00531856
- Sponsor's protocol ID
- C201
- Status last verified
- Oct 2016
- First submitted
- 18 Sep 2007
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-blind, Placebo-controlled, Safety and Tolerability Study of the Effects of Carbon Monoxide for Inhalation in Patients Receiving Kidney Transplants.
- ClinicalTrials.gov ID
- NCT00531856
- Acronym / sponsor ID
- C201
- Conditions
- Kidney Transplantation
- Keywords
- Kidney Transplant, Carbon Monoxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical Hold pending additional data review and protocol amendment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and tolerability of two carbon monoxide doses when administered as an inhaled gas for 1 hour in patients receiving kidney transplants.
Detailed description
The mechanisms by which carbon monoxide exerts its effects in preventing damage of the graft appear to vary among the models and organs with the common theme of carbon monoxide acting as a potent anti-inflammatory molecule. Carbon monoxide affects several intracellular signaling pathways. In addition, carbon monoxide generates increased levels of anti-inflammatory molecules.
Evaluate the safety and tolerability of three carbon monoxide dose levels consisting of a single 0.7 mg/kg dose and a single 2.0 mg/kg dose when administered post-operatively and a single 2.0 mg/kg dose, a single 3.0mg/kg dose and a 3.5 mg/kg dose when administered intra-operatively as an inhaled gas for 1 hour, by assessment of adverse events (AEs), vital signs, laboratory variables, serum carboxyhemoglobin (COHb), oxygenation, electrocardiography (ECG), and neurocognitive status in patients receiving kidney transplants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Inhaled carbon monoxide5.97 mg/L of carbon monoxide in 30% oxygen |
| 2 | Placebo comparator | Drug: Inhaled carbon monoxideOxygen 30% in Nitrogen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female receiving a kidney transplant from any donor type
- BMI between 16 and 36 inclusive
- Spontaneously breathing (non-intubated) with supplemental oxygen standardized at 2 liters via nasal cannula
- Hemodynamically stable with a systolic arterial pressure > 90 mmHg and a heart rate < 120 beats/min
- Acceptable transplantation candidate as judged by medical history, physical exam, ECG, vital signs, clinical chemistry, hematology, and urinalysis
Key exclusion criteria (7 listed)
- Exposure to any carbon monoxide source (e.g., fire, gas, or heavily polluted air) during the 48 hours prior to the study day
- Baseline blood level of COHb >2%
- Baseline hemoglobin (Hb) <10.0 g/dL
- Patients with significant underlying lung disease such as moderate or severe asthma, COPD, and interstitial lung disease
- Baseline oxygen saturation <95%
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 |
|---|---|---|
| Inhaled carbon monoxide0.7 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant | Drug | 1, 2 |
| Inhaled carbon monoxide2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours post transplant | Drug | 1, 2 |
| Inhaled carbon monoxide3.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant | Drug | 1, 2 |
| Inhaled Carbon Monoxide3.5 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant | Drug | 1, 2 |
| Inhaled Carbon Monoxide2.0 mg/kg carbon monoxide/placebo over one hour administered 12-48 hours during transplant. | Drug | 1, 2 |
Primary outcome
Evaluate the safety and tolerability of three carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants
Time frame: 28 days
1 secondary outcome
Characterize the pharmacokinetics of the inhaled carbon monoxide; Correlate the safety parameters to inhaled carbon monoxide and COHb levels; Assess laboratory values; Assess potential markers for the incidence of delayed graft function
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled carbon monoxide in people with Kidney Transplantation, run by Mallinckrodt at 3 sites 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 7 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate the safety and tolerability of three carbon monoxide dose levels when administered as an inhaled gas for 1 hour in patients receiving kidney transplants (time frame: 28 days). 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 19 Oct 2016.