Renal DiseasePhase 1NCT04556721
A Pharmacokinetic Study of Sugammadex in Dialysis Patients
A Phase 1 study testing Sugammadex in people with Renal Disease, run by Tetsuro Sakai at 1 site in United States.
Trial summary
The primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Disease
- What is being tested?
- Sugammadex
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 10 Sep 2021
- Phase
- Phase 1
- 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
- Age >18 years
- Currently on hemodialysis renal replacement therapy
- To be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively
- To be undergoing a surgical procedure requiring general anesthesia
- To have neuromuscular blockade for the surgical procedure
Who cannot join
- Diagnosed with a blood-borne infection (Hepatitis B or C, HIV)
- Allergy to rocuronium or sugammadex
- Planned renal transplant procedure
- Peritoneal dialysis patient
- Starting hemoglobin value of less than 8.0 g/dl
- Women who are currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients
The primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. Patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.
Read the detailed description
Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there is potential to clear sugammadex with high flux dialysis. We hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.
- Conditions
- Renal Disease
- Being tested
- Sugammadex
- Keywords
- Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called Bridion
On the day of surgery, after the establishment of general anesthesia, patients will be paralyzed via rocuronium. At the cessation of the case, an appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex | Experimental | After surgery and general anesthesia, a clinically-appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. Either 2 mg/kg or 4 mg/kg dosing will be used based on the level of neuromuscular blockade at the time of reversal. Administer as single IV bolus injection infused over 10 seconds into existing IV line. Dose is based on actual body weight (mg/kg). Receives: Drug: Sugammadex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Day of surgery and postoperative day 1 or 2 dialysis session
Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Day of surgery and postoperative day 1 or 2 dialysis session
Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Measured: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Secondary outcomes (1)
Number of participants experiencing any number of AEs deemed related to sugammadex drug
Adverse events will be reviewed in the subject electronic medical records (EMR) and relation to the study drug will be determined by the investigator and recorded by research staff. Any untoward medical occurrence resulting from the study drug will be recorded.
Measured: Day of surgery through up to post-operative day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start10 Sep 2021
- Primary completion10 Sep 2021
- Study completion10 Sep 2021
Why it stopped: Difficulty and lack of recruitment of the patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tetsuro Sakai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tetsuro Sakai, University of Pittsburgh
- Investigators
- Tetsuro Sakai, MD, PhD, MHA, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556721
- Sponsor's protocol ID
- STUDY19090331
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients
- ClinicalTrials.gov ID
- NCT04556721
- Acronym / sponsor ID
- STUDY19090331
- Conditions
- Renal Disease
- Keywords
- Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty and lack of recruitment of the patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tetsuro SakaiUniversity, hospital or other
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 10 Sep 2021 (actual)
- Study completion
- 10 Sep 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- 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 primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. Patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.
Detailed description
Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there is potential to clear sugammadex with high flux dialysis. We hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sugammadex | Experimental | Drug: SugammadexAfter surgery and general anesthesia, a clinically-appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. Either 2 mg/kg or 4 mg/kg dosing will be used based on the level of neuromuscular blockade at the time of reversal. Administer as single IV bolus injection infused over 10 seconds into existing IV line. Dose is based on actual body weight (mg/kg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Currently on hemodialysis renal replacement therapy
- To be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively
- To be undergoing a surgical procedure requiring general anesthesia
- To have neuromuscular blockade for the surgical procedure
Key exclusion criteria (6 listed)
- Diagnosed with a blood-borne infection (Hepatitis B or C, HIV)
- Allergy to rocuronium or sugammadex
- Planned renal transplant procedure
- Peritoneal dialysis patient
- Starting hemoglobin value of less than 8.0 g/dl
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 |
|---|---|---|
| SugammadexAlso: BridionOn the day of surgery, after the establishment of general anesthesia, patients will be paralyzed via rocuronium. At the cessation of the case, an appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. | Drug | Sugammadex |
Primary outcome
Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session
Time frame: Day of surgery and postoperative day 1 or 2 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Time frame: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Time frame: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session
Time frame: Day of surgery and postoperative day 1 or 2 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session
Time frame: Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Time frame: Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL).
1 secondary outcome
Number of participants experiencing any number of AEs deemed related to sugammadex drug
Time frame: Day of surgery through up to post-operative day 10
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 17 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Tetsuro Sakai, MD, PhD, MHA principal investigator
University of Pittsburgh Medical Center
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 Sugammadex in people with Renal Disease, run by Tetsuro Sakai 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 5 inclusion and 6 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 17 Sep 2021. 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?
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?
Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session (time frame: Day of surgery and postoperative day 1 or 2 dialysis session). The study lists 6 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 Sep 2021.