Kidney DiseasesNCT03095391
The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™
An observational study of Kidney Diseases and Renal Insufficiency, Chronic, run by FAST BioMedical at 2 sites in United States.
Trial summary
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury
- What is being tested?
- VFI and Iohexol
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2017to 20 Sep 2017
- Phase
- Observational
- 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
Study population: Community sample
Who may be able to join
- All Subjects/Patients:
- Males or females ≥ 18 and ≤ 75 years of age.
- Females must be of non-childbearing potential (eg, postmenopausal [defined as cessation of regular menstrual periods for at least 1 year confirmed by follicle-stimulating hormone (FSH) test] or surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation [documentation required] or be using a medically acceptable form of birth control [eg, a barrier method, intrauterine device, or hormonal contraception]) from screening until 30 days after last dose.
- Males who are sexually active and whose partners are females of childbearing potential must agree to practice abstinence or use condoms from screening through 90 days after administration of the last dose of study drug, and their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of study drug.
- Males must agree to not donate sperm from screening through 90 days after administration of the last dose of study drug.
- Subjects must be able to communicate effectively with the study personnel.
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- Subjects must be informed of the nature and risks of the study and give written informed consent prior to screening.
- Body mass index ≥ 18.0 and ≤ 40.0 kg/m2, and body weight ≥ 40 kg at screening and CRU admission.
- BMI = weight (kg)/(height [m])2
- Subjects with Normal Renal Function (Cohorts 1 and 2):
- Subjects must have an eGFR (calculated using the CKD-EPI Equation) ≥ 60 mL/min/1.73 m2 consistent with the National Kidney Foundation stages 1 and 2 of CKD.
- Subjects must be otherwise healthy and without clinically significant abnormalities as assessed by review of medical and surgical history, physical examination, vital signs measurement, pulse oximetry, ECG, and clinical laboratory evaluations conducted at screening and CRU admission. A single repeat measurement/test may be performed, at the discretion of the physician, to confirm vital signs, pulse oximetry, ECG, and clinical laboratory tests abnormalities (ie, to confirm that a subject is eligible).
- Patients with Renal Impairment (Cohorts 3 and 4):
- Patients in Cohort 3 must have an eGFR (calculated using the CKD-EPI Equation) ≥ 30 and < 60 mL/min/1.73 m2 consistent with the National Kidney Foundation stages 3a and 3b of CKD.
- Patients in Cohort 4 must have an eGFR (calculated using the CKD-EPI Equation) ≥ 15 and < 30 mL/min/1.73 m2 consistent with the National Kidney Foundation stage 4 of CKD.
- Patients may have clinical, ECG, and clinical laboratory findings consistent with their degree of renal dysfunction as assessed by review of medical and surgical history, physical examination, vital signs measurement, pulse oximetry, ECG, and clinical laboratory evaluations conducted at screening and CRU admission. A single repeat measurement/test may be performed, at the discretion of the physician, to confirm vital signs, pulse oximetry, ECG, and clinical laboratory tests abnormalities (ie, to confirm that a subject is eligible).
Who cannot join
- All Subjects/Patients:
- Female subject/patient is pregnant or breastfeeding.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with the distribution, metabolism, or excretion of drugs.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 6 months of screening.
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- Systolic blood pressure (BP) < 90 or > 160 mmHg or diastolic BP < 50 or > 100 mmHg measured after the subject has been resting quietly in a supine position or in the most recumbent position possible for at least 5 minutes at screening or CRU admission. A single repeat measurement may be performed to confirm vital signs abnormalities (ie, to confirm that a subject is eligible).
- Heart rate (HR) < 40 or > 105 beats per minute (bpm) measured on ECG after the subject has been resting quietly in a supine position or in the most recumbent position possible for at least 5 minutes at screening or CRU admission. A single repeat measurement may be performed to confirm ECG abnormalities (ie, to confirm that a subject is eligible).
- Has taken other investigational drugs or participated in any clinical study within 30 days or 5 half-lives of the investigational drug's PK, PD, or biological activity, whichever is longer, prior to first dose of study drug in this study.
- Prior exposure to VFI or known allergy to dextrans.
- History of any clinically significant allergic or negative reactions, side effects, or anaphylaxis to iodine, dyes, shellfish, isotopes, or dextran molecules.
- Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to study participation.
- Positive screen for human immunodeficiency virus (HIV)-1 or HIV-2 antibodies, hepatitis B virus surface antigen (HBsAg), or hepatitis C virus (HCV) antibody.
- Diagnosis of acquired immune deficiency syndrome (AIDS).
- History of nephrectomy or kidney transplant.
- History of liver disease or screening liver function tests which exceed 2 × the upper limit of normal (ULN) or an albumin value of < 3 mg/dL.
- International normalized ratio (INR) > 1.5 × ULN or a platelet count < 50,000.
- Presence of significant hemodynamic instabilities.
- Loss of Limb- as this alters the validity of eGFR and estimated PV equations.
- Any other condition or prior therapy that, in the investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
- Involved in the planning or conduct of this study.
- Inability to tolerate venipuncture or poor venous access.
- Unwilling to abstain from alcohol from 24 hours prior to admission until discharge from the CRU.
- Unwilling to abstain from strenuous activity (as assessed by the investigator) from 72 hours prior to admission until discharge from the CRU.
- Unwilling or unlikely to comply with the requirements of the study.
- Subjects with Normal Renal Function (Cohorts 1 and 2):
- Positive urine drugs of abuse or alcohol screen.
- Use of prescription medications or any drugs that induce or inhibit study drug specific CYP(s) within 14 days or 5 half-lives, whichever is longer, of administration of the first dose of study drug.
- Use of over the-counter (OTC) drugs (including herbal preparations) within 7 days or 5 half lives, whichever is longer, prior to administration of the first dose of study drug.
- Patients with Renal Impairment (Cohorts 3 and 4):
- Clinically significant ongoing bleeding, changing hemoglobin, or experienced significant blood loss within 2 weeks prior to administration of the first dose of study drug.
- Positive urine drugs of abuse (except for prescribed medications) or alcohol screen.
- Use of anticoagulants and nonsteroidal anti-inflammatory drugs within 3 days prior to administration of the first dose of study drug.
- Use of inotropes or vasopressors.
- Any other condition or prior therapy that, in the investigator's opinion, is likely to deteriorate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama Birmingham, Division of Nephrology
Birmingham, Alabama, 35294
ICON Early Phase Services, LLC
San Antonio, Texas, 78209
About this study
Official title: A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™ in Healthy Subjects and Patients With Varying Degrees of Renal Impairment
This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.
Read the detailed description
For Cohorts 1 and 2, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the clinical research unit (CRU) on Day -1, at which time assessments will be performed, and results from both screening and Day -1 (inclusion/exclusion criteria, body weight, height [screening only], body mass index [BMI], medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, follicle-stimulating hormone [FSH; screening only] and pregnancy test [females only], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility.
For Cohorts 3 and 4, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the CRU on Day 1, at which time assessments will be performed and results from both screening and predose administration testing (inclusion/exclusion criteria, body weight, height [screening only], BMI, medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, FSH and pregnancy test [screening only], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility.
Cohort 1:
Eligible subjects will receive a single dose of VFI followed 130 minutes later by a 350 mL infusion of 5% albumin up to maximum volume of 7 mL/kg over 30 minutes on Day 1. Subjects will remain resident in the CRU for at least 24 hours after VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for an end-of-study (EOS) visit on Day 21 (± 1 day).
Cohort 2:
Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI. Subjects will remain resident in the CRU for at least 24 hours after the second VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for follow-up visits on Days 5 (± 1 day), 9 (± 1 day), and 16 (± 1 day) and an EOS visit on Day 22 (± 1 day).
Cohorts 3 and 4:
Eligible patients will receive a single dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1. Patients will remain in the CRU through the 12-hour sample collection after VFI administration for safety, PK, and PD assessments. . Patients will stay at a local hotel near the CRU and will return to the CRU on Day 2 for the 24-hour sample collection. Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 15 (± 1 day) and an EOS visit on Day 21 (± 1 day).
- Conditions
- Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury, Urologic Diseases, Renal Insufficiency
- Being tested
- VFI, Iohexol
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury, Urologic Diseases, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VFIDevice
The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
IohexolDevice
Iohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | GFR: ≥ 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: none Comparator dose: none Receives: Device: VFI | |
| Cohort 2 | GFR: ≥ 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 2 Comparator: Iohexol 5 mL Comparator dose: 1 Receives: Device: VFI; Device: Iohexol | |
| Cohort 3 | GFR: ≥ 30 and < 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: Iohexol 5 mL Comparator dose: 1 Receives: Device: VFI; Device: Iohexol | |
| Cohort 4 | GFR: ≥ 15 and < 30 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: Iohexol 5 mL Comparator dose: 1 Receives: Device: VFI; Device: Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
- Subjects will be monitored for AEs from administration of the first dose of study drug through the end of study visit
- Abnormal clinical laboratory tests, physical examination findings, 12-lead electrocardiograms (ECGs), and vital signs including pulse oximetry that (1) are considered clinically significant initially and on confirmation, (2) require a subject to be discontinued from the study, (3) require a subject to receive treatment, or (4) require a change or discontinuation from the study drug (if applicable) will be recorded as AEs
Measured: 21 ± 1 days
Maximum observed plasma concentration (Cmax)
Measured: 21 ± 1 days
Time that Cmax was observed (tmax)
Measured: 21 ± 1 days
Area under the plasma concentration-time curve (AUC) from time 0 to 12 hours (AUC0 12: FD001 only)
Measured: 21 ± 1 days
AUC from time 0 to the time of the last quantifiable concentration (AUClast)
Measured: 21 ± 1 days
AUC from time 0 extrapolated to infinity (AUCinf)
Measured: 21 ± 1 days
Terminal elimination half-life (t½)
Measured: 21 ± 1 days
Terminal elimination rate constant (λz)
Measured: 21 ± 1 days
Total body clearance (CL)
Measured: 21 ± 1 days
Renal clearance (CLr; FD001 only)
Measured: 21 ± 1 days
Volume of distribution during the terminal phase (Vz)
Measured: 21 ± 1 days
Volume of distribution at steady state (Vss)
Measured: 21 ± 1 days
Fraction of dose excreted unchanged in the urine (Ae0-12)
Measured: 21 ± 1 days
Secondary outcomes (6)
PV as assessed by FAST PV and mGFR Technology
Measured: 21 ± 1 days
PV as assessed by Nadler's formula
Measured: 21 ± 1 days
Changes in PV after fluid challenge
Measured: 21 ± 1 days
Repeatability of GFR measurements over 24 hours
Measured: 21 ± 1 days
mGFR as assessed by FAST VFI and Iohexol clearance methods
Measured: 21 ± 1 days
Estimated GFR (eGFR) (calculated by the Modification of Diet in Renal Disease [MDRD], Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine and Cockcroft-Gault equations)
Measured: 21 ± 1 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start13 Jun 2017
- Primary completion20 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- FAST BioMedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Emmanuel DeNoia, MD, Principal investigator, ICON plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095391
- Sponsor's protocol ID
- 36770001
- Status last verified
- Oct 2017
- First submitted
- 20 Mar 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™ in Healthy Subjects and Patients With Varying Degrees of Renal Impairment
- ClinicalTrials.gov ID
- NCT03095391
- Acronym / sponsor ID
- 36770001
- Conditions
- Kidney Diseases, Renal Insufficiency, Chronic, Acute Kidney Injury, Urologic Diseases, Renal Insufficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- FAST BioMedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 20 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 29 Mar 2017 (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 is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.
Detailed description
For Cohorts 1 and 2, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the clinical research unit (CRU) on Day -1, at which time assessments will be performed, and results from both screening and Day -1 (inclusion/exclusion criteria, body weight, height [screening only], body mass index [BMI], medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, follicle-stimulating hormone [FSH; screening only] and pregnancy test [females only], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility.
For Cohorts 3 and 4, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the CRU on Day 1, at which time assessments will be performed and results from both screening and predose administration testing (inclusion/exclusion criteria, body weight, height [screening only], BMI, medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, FSH and pregnancy test [screening only], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility.
Cohort 1:
Eligible subjects will receive a single dose of VFI followed 130 minutes later by a 350 mL infusion of 5% albumin up to maximum volume of 7 mL/kg over 30 minutes on Day 1. Subjects will remain resident in the CRU for at least 24 hours after VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for an end-of-study (EOS) visit on Day 21 (± 1 day).
Cohort 2:
Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI. Subjects will remain resident in the CRU for at least 24 hours after the second VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for follow-up visits on Days 5 (± 1 day), 9 (± 1 day), and 16 (± 1 day) and an EOS visit on Day 22 (± 1 day).
Cohorts 3 and 4:
Eligible patients will receive a single dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1. Patients will remain in the CRU through the 12-hour sample collection after VFI administration for safety, PK, and PD assessments. . Patients will stay at a local hotel near the CRU and will return to the CRU on Day 2 for the 24-hour sample collection. Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 15 (± 1 day) and an EOS visit on Day 21 (± 1 day).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: VFIGFR: ≥ 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: none Comparator dose: none |
| Cohort 2 | – | Device: VFI, Device: IohexolGFR: ≥ 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 2 Comparator: Iohexol 5 mL Comparator dose: 1 |
| Cohort 3 | – | Device: VFI, Device: IohexolGFR: ≥ 30 and < 60 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: Iohexol 5 mL Comparator dose: 1 |
| Cohort 4 | – | Device: VFI, Device: IohexolGFR: ≥ 15 and < 30 mL/min/1.73 m2 VFI dose: 47 mg/3 mL Number of doses: 1 Comparator: Iohexol 5 mL Comparator dose: 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (16 listed)
- Males or females ≥ 18 and ≤ 75 years of age.
- Females must be of non-childbearing potential (eg, postmenopausal [defined as cessation of regular menstrual periods for at least 1 year confirmed by follicle-stimulating hormone (FSH) test] or surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation [documentation required] or be using a medically acceptable form of birth control [eg, a barrier method, intrauterine device, or hormonal contraception]) from screening until 30 days after last dose.
- Males who are sexually active and whose partners are females of childbearing potential must agree to practice abstinence or use condoms from screening through 90 days after administration of the last dose of study drug, and their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of study drug.
- Males must agree to not donate sperm from screening through 90 days after administration of the last dose of study drug.
- Subjects must be able to communicate effectively with the study personnel.
Key exclusion criteria (35 listed)
- Female subject/patient is pregnant or breastfeeding.
- History or presence of conditions which, in the judgment of the investigator, are known to interfere with the distribution, metabolism, or excretion of drugs.
- History or presence of conditions that may place the subject at increased risk as determined by the investigator.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study.
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 6 months of screening.
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 |
|---|---|---|
| VFIThe IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached. | Device | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| IohexolIohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration. | Device | Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Incidence of serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
Time frame: 21 ± 1 days
* Subjects will be monitored for AEs from administration of the first dose of study drug through the end of study visit * Abnormal clinical laboratory tests, physical examination findings, 12-lead electrocardiograms (ECGs), and vital signs including pulse oximetry that (1) are considered clinically significant initially and on confirmation, (2) require a subject to be discontinued from the study, (3) require a subject to receive treatment, or (4) require a change or discontinuation from the study drug (if applicable) will be recorded as AEs
Maximum observed plasma concentration (Cmax)
Time frame: 21 ± 1 days
Time that Cmax was observed (tmax)
Time frame: 21 ± 1 days
Area under the plasma concentration-time curve (AUC) from time 0 to 12 hours (AUC0 12: FD001 only)
Time frame: 21 ± 1 days
AUC from time 0 to the time of the last quantifiable concentration (AUClast)
Time frame: 21 ± 1 days
AUC from time 0 extrapolated to infinity (AUCinf)
Time frame: 21 ± 1 days
Terminal elimination half-life (t½)
Time frame: 21 ± 1 days
Terminal elimination rate constant (λz)
Time frame: 21 ± 1 days
Total body clearance (CL)
Time frame: 21 ± 1 days
Renal clearance (CLr; FD001 only)
Time frame: 21 ± 1 days
Volume of distribution during the terminal phase (Vz)
Time frame: 21 ± 1 days
Volume of distribution at steady state (Vss)
Time frame: 21 ± 1 days
Fraction of dose excreted unchanged in the urine (Ae0-12)
Time frame: 21 ± 1 days
6 secondary outcomes
PV as assessed by FAST PV and mGFR Technology
Time frame: 21 ± 1 days
PV as assessed by Nadler's formula
Time frame: 21 ± 1 days
Changes in PV after fluid challenge
Time frame: 21 ± 1 days
Repeatability of GFR measurements over 24 hours
Time frame: 21 ± 1 days
mGFR as assessed by FAST VFI and Iohexol clearance methods
Time frame: 21 ± 1 days
Estimated GFR (eGFR) (calculated by the Modification of Diet in Renal Disease [MDRD], Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] Creatinine and Cockcroft-Gault equations)
Time frame: 21 ± 1 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 26 Dec 2018.
- 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.
Emmanuel DeNoia, MD principal investigator
ICON plc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Diseases and Renal Insufficiency, Chronic, run by FAST BioMedical at 2 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 16 inclusion and 35 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Incidence of serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs) (time frame: 21 ± 1 days). The study lists 13 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 26 Dec 2018.