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Renal ImpairmentPhase 1NCT04865393

Phase 1 Study of PK and Safety of SPR206 in Subjects With Various Degrees Of Renal Function

A Phase 1 study testing SPR206 in people with Renal Impairment, run by Spero Therapeutics at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Renal Impairment
What is being tested?
SPR206
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesNew Zealand
Study dates
8 Jun 2021to 6 Dec 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • BMI ≥ 18.5 and ≤ 39.9 (kg/m2) and weight between 50.0 and 130.0 kg (inclusive)
  • Medically healthy without clinically significant abnormalities (Healthy Volunteers) or medically stable without clinically significant acute or chronic illness (Subjects with varying degrees of Renal Disease)
  • Normal renal function with eGFR ≥90 mL/min/1.73m2 (Cohort 1), or renal insufficiency with eGFR 60 to <90 mL/min/1.73m2 (Cohort 2), 30 to <60 mL/min/1.73m2 (Cohort 3), or <30 mL/min/1.73m2 (Cohort 4), calculated using Modification of Diet in Renal Disease (MDRD). Subjects with ESRD must be receiving hemodialysis at least 3 times per week for at least 3 months at Screening (Cohort 5 only)
  • Non-smoker for at least 1 month prior to screening for the study
  • Ability and willingness to abstain from alcohol, caffeine, xanthine-containing beverages or food
  • Other inclusion criteria per protocol

Who cannot join

  • Any clinically significant medical history or abnormal findings upon physical examination, or clinical laboratory tests, not specifically excluded in other criteria below that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
  • Electrocardiogram (ECG) with QTcF interval duration equal or greater than 500 msec
  • Hemoglobin (HB), hematocrit (HCT), white blood cell count (WBC), or platelet count less than the lower limit of normal range of the reference laboratory (Cohort 1). HB <8.5 gm/dL, WBC ≤3,000 cells/μL or platelet count ≤100,000 cells/μL (Cohorts 2-5)
  • Results of biochemistry tests for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin greater than 1.5 X the upper limit of normal (ULN) for the reference laboratory
  • Recent history (within 6 months) of known or suspected Clostridium difficile infection
  • History of chronic liver disease, cirrhosis, or biliary disease
Show all 12Show fewer
  • History of seizure disorder except childhood history of febrile seizures
  • Positive urine drug/alcohol testing
  • Positive testing for human immunodeficiency virus1/2 (HIV 1/2), hepatitis B surface antigen (HBsAg) or hepatitis C (HCV) antibodies
  • History of substance abuse or alcohol abuse
  • Known history of clinically significant hypersensitivity reaction or anaphylaxis to any medication
  • Other exclusion criteria per protocol

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

  • Medical Facility

    Auckland, 1010

  • Medical Facility

    Christchurch, 8011

Other trials in New Zealand

About this study

Official title: A Phase 1, Open-label Study to Assess the Safety and Pharmacokinetics of SPR206 Following a Single IV Dose of SPR206 in Subjects With Varying Degrees of Renal Function

Evaluation of the pharmacokinetics (PK) of SPR206 in subjects with normal renal function, subjects with various degrees of renal insufficiency, and subjects with end-stage renal disease (ESRD) receiving hemodialysis (HD) therapy.

Being tested
SPR206
Keywords
End State Renal Disease (ESRD), Renal Insufficiency, Renal Impairment, Renal Disease, Hemodialysis
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.

  • SPR206Drug

    SPR206 100 mg single-dose IV infused over 1 hour

Study groups in NCT04865393
Study groupRoleWhat they receive
SPR206ExperimentalSPR206 100mg single-dose IV infused over 1 hour
Receives: Drug: SPR206

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the maximum plasma concentration (Tmax)

    Measured: 36 hours after start of study drug IV infusion

  2. Maximum plasma concentration (Cmax)

    Measured: 36 hours after start of study drug IV infusion

  3. Area under the concentration-time curve from time 0 to last measurable timepoint (AUC0-t)

    Measured: 36 hours after start of study drug IV infusion

  4. Area under the concentration-time curve from time 0 to infinity (AUC0-∞)

    Measured: 36 hours after start of study drug IV infusion

Secondary outcomes (21)

  1. Area under the concentration-time curve from time 0 to 8 hours (AUC0-8)

    Measured: 8 hours after start of study drug IV infusion

  2. Terminal Elimination Rate Constant (kel)

    Measured: 36 hours after start of study drug IV infusion

  3. Terminal half-life (t1/2)

    Measured: 36 hours after start of study drug IV infusion

  4. Total body clearance (CL)

    Measured: 36 hours after start of study drug IV infusion

  5. Renal clearance (CLR)

    Measured: 36 hours after start of study drug IV infusion

  6. Steady-state volume of distribution (Vss)

    Measured: 36 hours after start of study drug IV infusion

  7. Amount of drug excreted in urine by interval (Aet) for Cohorts 1-4

    Measured: 36 hours after start of study drug IV infusion

  8. Cumulative amount of drug excreted in urine at the end of each interval (Aeu) for Cohorts 1-4

    Measured: 36 hours after start of study drug IV infusion

  9. Fraction of drug excreted in the urine expressed as a percentage (Ae%) for Cohorts 1-4

    Measured: 36 hours after start of study drug IV infusion

  10. Fraction of dose excreted in the urine over a collection interval (Fe) for Cohorts 1-4

    Measured: 36 hours after start of study drug IV infusion

  11. Cumulative fraction of dose excreted in the urine over (Feu) for Cohorts 1-4

    Measured: 36 hours after start of study drug IV infusion

  12. Extraction ratio (ER) for subjects on dialysis (Cohort 5)

    Measured: Up to 1 day post dose - between start and end of hemodialysis

  13. Estimated hemodialysis clearance (CLHD) for subjects on dialysis (Cohort 5)

    Measured: Up to 1 day post dose - between start and end of hemodialysis

  14. Amount of the dose removed by hemodialysis (XHD) for subjects on dialysis (Cohort 5)

    Measured: Up to 1 day post dose - between start and end of hemodialysis

  15. Incidence of Treatment-Emergent Adverse Events

    To assess the incidents of treatment-emergent adverse events following SPR206 intravenous dose administration. AEs will be classified by System Organ Class (SOC) and Preferred Term (PT). Incidence, frequency, severity and duration will be presented.

    Measured: 14 days post start of last study drug IV infusion

  16. Incidence of abnormal vital sign assessments - blood pressure

    To assess the incidents of abnormal systolic and diastolic blood pressure assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented.

    Measured: 14 days post study drug IV infusion

  17. Incidence of abnormal vital sign assessments - body temperature

    To assess the incidents of abnormal body temperature assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Significant changes from baseline will be presented.

    Measured: 14 days post study drug IV infusion

  18. Incidence of abnormal physical exam assessments

    To assess the incidents of abnormal body system assessments following SPR206 intravenous dose administration. Changes from baseline in physical examination findings will be classified as Normal, Abnormal NCS, and Abnormal CS. Frequency counts will be presented.

    Measured: 14 days post study drug IV infusion

  19. Incidence of abnormal ECG assessments - heart rate

    To assess the incidents of abnormal heart rate assessment following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) for heart rate will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.

    Measured: 14 days post study drug IV infusion

  20. Incidence of abnormal ECG assessments - PR, RR, QRS, QT and QTcF interval

    To assess the incidents of abnormal PR interval, RR interval, QRS interval, QT interval and QTcF interval assessments following SPR206 intravenous dose administration. Cardiac (12-Lead ECG) results will be classified as normal, abnormality that is NCS, and CS abnormality. Frequency counts by dose group and timepoint of collection will be presented.

    Measured: 14 days post study drug IV infusion

  21. Incidence of abnormal safety laboratory assessments

    To assess the incidents of abnormal hematology, serum chemistry, coagulation and urinalysis assessments following SPR206 intravenous dose administration. Values and changes from baseline at each scheduled time-point will be summarized using descriptive statistics (n, mean, SD, median, minimum, and maximum). Frequency counts of significant changes from baseline will be presented.

    Measured: 14 days post study drug IV infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start8 Jun 2021
  3. Primary completion1 Dec 2021
  4. Study completion6 Dec 2021

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04865393
Sponsor's protocol ID
SPR206-103
Other IDs
CDMRP-JW180095-B
Status last verified
Dec 2021
First submitted
26 Apr 2021
Last updated
15 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPR206 in people with Renal Impairment, run by Spero Therapeutics at 2 sites in New Zealand.

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 12 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 15 Apr 2024. 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 New Zealand. 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?

Time to the maximum plasma concentration (Tmax) (time frame: 36 hours after start of study drug IV infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04865393.

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 15 Apr 2024.

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