End Stage Renal DiseasePhase 1NCT04699656
Plazomicin Study in ESRD Patients Receiving IHD
A Phase 1 study testing Plazomicin Injection in people with End Stage Renal Disease, run by Cipla USA Inc. at 1 site in United States.
Trial summary
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Plazomicin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 9 Jun 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects between 18 and 75 years of age with a BMI ≥19 to ≤42 kg/m2 and weight of ≥40 kg
- Pre-existing ESRD requiring in-center IHD for a minimum of 3 months on a schedule of three IHD sessions per week with the third weekly IHD session occurring at least 72 hours before the first weekly IHD session of the subsequent week (e.g. Monday/Wednesday/Friday or Tuesday/Thursday/Saturday)
- Females of childbearing potential must not be breast-feeding, must have a negative serum pregnancy test at screening, and must use a highly effective method of contraception (includes hormonal implants, intrauterine devices, injectable hormones, oral hormonal contraceptives, prior hysterectomy, prior bilateral oophorectomy, or a vasectomized partner whose vasectomy was performed 4 months or more prior to dosing on Day 1) or be abstinent from sexual activity for at least 1 month prior to dosing on Day 1, during the study and through 30 days following the last dose of study drug. Females of non-childbearing potential, defined as women who have not had a period for 12 consecutive months prior to dosing on Day 1, may be enrolled.
- Willing to comply with all study activities and procedures and have provided written informed consent prior to any study procedures and have signed and dated a Health Insurance Portability and Accountability Act (HIPAA) authorization form.
Who cannot join
- Subjects with any medical, psychological, or social condition which, in the opinion of the Investigator, would prevent the subject from fully participating in the study, would represent a concern for study compliance or would constitute a safety concern to the subject.
- Unstable cardiovascular disease per the Investigator, including:
- Heart rate <40 or >110 beats per minute (bpm) or QT interval corrected using Fridericia's formula (QTcF) >500 msec.
- Uncontrolled hypertension, asthma, diabetes (type I or type II), thyroid disease, or seizure disorder
- Myasthenia gravis or any other neuromuscular disorder.
- Known infection with hepatitis B (antigen positive), hepatitis C (antibody positive), or human immunodeficiency virus (HIV). Subjects with clinically insignificant or adequately treated hepatitis C may be allowed at the discretion of the Investigator.
Show all 19Show fewer
- Active malignancy; carcinoma in situ of the prostate or cervix or basal cell or squamous cell carcinoma of the skin are permitted.
- Presence of functioning transplant organ or blood procedure.
- Significant change in either over-the-counter or prescription medications or supplements within 3 months prior to dosing, defined as any new medication or any dosage adjustment that is significant in the judgment of the Investigator.
- History of significant hearing loss or a family history of hearing loss, excluding age-related (≥65 years) hearing loss. A prior diagnosis of sensorineural hearing loss or Ménière's disease or receipt of any potentially ototoxic agent within 30 prior to the start of screening.
- Subjects who received a systemic aminoglycoside within 90 days of the start of screening.
- Clinically significant illness, including viral syndromes within three weeks of dosing.
- Current participation in a clinical study of an investigational product.
- Subjects who took any investigational medication/therapy within 30 days or 5 half-lives, whichever is longer, before dosing of plazomicin.
- Subjects with active alcoholism and/or drug/chemical abuse in the opinion of the Investigator. Also, consumption of any amount of ethanol within 48 hours of plazomicin dosing.
- Subjects who donated more than 500 mL of blood within 60 days prior to start of screening.
- Previous participation in this or any other plazomicin study.
- Known hypersensitivity to aminoglycosides or any component of plazomicin injection.
- The subject is an employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: A Phase 1 Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Administration of Plazomicin in Subjects With End Stage Renal Disease (ESRD) Receiving Intermittent Hemodialysis (IHD)
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.
Read the detailed description
This is a Phase 1, single-center, open-label, single-dose study to evaluate the PK of a single dose of plazomicin (30-minute IV infusion at 2.5 mg/kg) when administered prior to and after IHD in subjects with ESRD.
The study will consist of a screening period of up to 28 days and two treatment periods, with at least a 7-day washout between dosing in each treatment period. The start of the study is defined as the date that the first subject is screened following signing of an informed consent form (ICF).
In Period 1 (Week 1), the dosing day will be concomitant with the 3rd weekly IHD session, which must be at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) within 1 hour after IHD is completed. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
In Period 2 (Week 2), the dosing day will occur on the day of the 3rd weekly IHD session, which must be at least 7 days after the first dose and at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) before IHD is started. The plazomicin infusion should be completed within 30 minutes of IHD initiation. During IHD, the total dialysate will be collected in a large collection container and pooled at 1-hour intervals (0-1, 1-2, 2-3, etc. for the duration of the IHD session). From each hourly interval (including any partial interval at end of dialysis), an aliquot sample of dialysate will be collected for PK analysis. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
Safety assessments will include physical examination findings, vital signs (blood pressure, pulse rate, respiration rate, and oral temperature), clinical laboratory evaluations, and monitoring of adverse events (AEs). Adverse events will be assessed from the time the subject signs the ICF until exit from the study.
The site will attempt to contact all subjects (including subjects who terminate the study early) via phone call approximately 14 days after the last dose of study drug to determine if any AE has occurred since the last study visit. Subjects reporting AEs may be asked to return to the site for further assessment.
- Conditions
- End Stage Renal Disease
- Being tested
- Plazomicin Injection
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plazomicin InjectionDrug
Also called Zemdri
single dose of plazomicin
| Study group | Role | What they receive |
|---|---|---|
| Plazomicin Injection | Experimental | plazomicin (30-minute IV infusion at 2.5 mg/kg) single dose given before IHD and single dose given after IHD Receives: Drug: Plazomicin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
o Maximum observed plasma drug concentration (Cmax)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Time to maximum observed plasma concentration (Tmax)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Area under the plasma concentration time curve from time 0 to the last measurable concentration (AUC0-t)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Area under the plasma concentration time curve extrapolated to infinity (AUCinf)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Terminal elimination half-life (t1/2)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Total plasma clearance (CL)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Volume of distribution during the terminal elimination phase (Vz)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
o Terminal elimination rate constant (λz)
Plasma PK parameter for plazomicin before and after IHD
Measured: 30 days
Secondary outcomes (1)
• Adverse events (AEs)
Safety assessment; An overall summary will be generated presenting the frequency and percentage of subjects and the number of treatment-emergent adverse events (TEAEs).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start5 Jan 2021
- Primary completion8 Mar 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cipla USA Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrice P Rioux, MD, PhD, Study director, Cipla USA Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699656
- Sponsor's protocol ID
- CPH-002-CL-013
- Status last verified
- Mar 2022
- First submitted
- 28 Dec 2020
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intravenous Administration of Plazomicin in Subjects With End Stage Renal Disease (ESRD) Receiving Intermittent Hemodialysis (IHD)
- ClinicalTrials.gov ID
- NCT04699656
- Acronym / sponsor ID
- CPH-002-CL-013
- Conditions
- End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cipla USA Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 7 Jan 2021 (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.
This study is being conducted to directly characterize the pharmacokinetic (PK) profile of plazomicin following administration of a single oral dose before and after IHD in subjects with ESRD. This PK assessment will be used to provide appropriate plazomicin dosing recommendations for patients with ESRD receiving IHD.
Detailed description
This is a Phase 1, single-center, open-label, single-dose study to evaluate the PK of a single dose of plazomicin (30-minute IV infusion at 2.5 mg/kg) when administered prior to and after IHD in subjects with ESRD.
The study will consist of a screening period of up to 28 days and two treatment periods, with at least a 7-day washout between dosing in each treatment period. The start of the study is defined as the date that the first subject is screened following signing of an informed consent form (ICF).
In Period 1 (Week 1), the dosing day will be concomitant with the 3rd weekly IHD session, which must be at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) within 1 hour after IHD is completed. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
In Period 2 (Week 2), the dosing day will occur on the day of the 3rd weekly IHD session, which must be at least 7 days after the first dose and at least 72 hours before the 1st weekly IHD session of the subsequent Week. All subjects will receive a single dose of plazomicin (30 minute IV infusion at 2.5 mg/kg) before IHD is started. The plazomicin infusion should be completed within 30 minutes of IHD initiation. During IHD, the total dialysate will be collected in a large collection container and pooled at 1-hour intervals (0-1, 1-2, 2-3, etc. for the duration of the IHD session). From each hourly interval (including any partial interval at end of dialysis), an aliquot sample of dialysate will be collected for PK analysis. PK samples will be collected at specified time points from 0.6 hours to 72 hours after completion of the plazomicin infusion. Collection of all PK samples must be completed prior to the next scheduled IHD.
Safety assessments will include physical examination findings, vital signs (blood pressure, pulse rate, respiration rate, and oral temperature), clinical laboratory evaluations, and monitoring of adverse events (AEs). Adverse events will be assessed from the time the subject signs the ICF until exit from the study.
The site will attempt to contact all subjects (including subjects who terminate the study early) via phone call approximately 14 days after the last dose of study drug to determine if any AE has occurred since the last study visit. Subjects reporting AEs may be asked to return to the site for further assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plazomicin Injection | Experimental | Drug: Plazomicin Injectionplazomicin (30-minute IV infusion at 2.5 mg/kg) single dose given before IHD and single dose given after IHD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects between 18 and 75 years of age with a BMI ≥19 to ≤42 kg/m2 and weight of ≥40 kg
- Pre-existing ESRD requiring in-center IHD for a minimum of 3 months on a schedule of three IHD sessions per week with the third weekly IHD session occurring at least 72 hours before the first weekly IHD session of the subsequent week (e.g. Monday/Wednesday/Friday or Tuesday/Thursday/Saturday)
- Females of childbearing potential must not be breast-feeding, must have a negative serum pregnancy test at screening, and must use a highly effective method of contraception (includes hormonal implants, intrauterine devices, injectable hormones, oral hormonal contraceptives, prior hysterectomy, prior bilateral oophorectomy, or a vasectomized partner whose vasectomy was performed 4 months or more prior to dosing on Day 1) or be abstinent from sexual activity for at least 1 month prior to dosing on Day 1, during the study and through 30 days following the last dose of study drug. Females of non-childbearing potential, defined as women who have not had a period for 12 consecutive months prior to dosing on Day 1, may be enrolled.
- Willing to comply with all study activities and procedures and have provided written informed consent prior to any study procedures and have signed and dated a Health Insurance Portability and Accountability Act (HIPAA) authorization form.
Key exclusion criteria (19 listed)
- Subjects with any medical, psychological, or social condition which, in the opinion of the Investigator, would prevent the subject from fully participating in the study, would represent a concern for study compliance or would constitute a safety concern to the subject.
- Unstable cardiovascular disease per the Investigator, including:
- Myasthenia gravis or any other neuromuscular disorder.
- Known infection with hepatitis B (antigen positive), hepatitis C (antibody positive), or human immunodeficiency virus (HIV). Subjects with clinically insignificant or adequately treated hepatitis C may be allowed at the discretion of the Investigator.
- Active malignancy; carcinoma in situ of the prostate or cervix or basal cell or squamous cell carcinoma of the skin are permitted.
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 |
|---|---|---|
| Plazomicin InjectionAlso: Zemdrisingle dose of plazomicin | Drug | Plazomicin Injection |
Primary outcome
o Maximum observed plasma drug concentration (Cmax)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Time to maximum observed plasma concentration (Tmax)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Area under the plasma concentration time curve from time 0 to the last measurable concentration (AUC0-t)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Area under the plasma concentration time curve extrapolated to infinity (AUCinf)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Terminal elimination half-life (t1/2)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Total plasma clearance (CL)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Volume of distribution during the terminal elimination phase (Vz)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
o Terminal elimination rate constant (λz)
Time frame: 30 days
Plasma PK parameter for plazomicin before and after IHD
1 secondary outcome
• Adverse events (AEs)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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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.
Patrice P Rioux, MD, PhD study director
Cipla USA Inc.
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 Plazomicin Injection in people with End Stage Renal Disease, run by Cipla USA Inc. 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 4 inclusion and 19 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: finished, as of the sponsor's last update on 9 Mar 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
o Maximum observed plasma drug concentration (Cmax) (time frame: 30 days). The study lists 8 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 9 Mar 2022.