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Renal ImpairmentPhase 1NCT02975388

A Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics (PK) of RO7079901

A Phase 1 study testing RO7079901 in people with Renal Impairment, run by Hoffmann-La Roche at 5 sites in United States.

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

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Renal Impairment
What is being tested?
RO7079901
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
20 Dec 2016to 6 Jul 2017
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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) between 18 and 38 kilograms per square-meter (kg/m^2) and body weight of at least 45 kilograms (kg)
  • Control group participants, Part 1 only:
  • Normal renal function based on creatinine clearance greater than or equal to (>=) 90 milliliters per minute (mL/min) at the Screening visit
  • Healthy for age-group, as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG)
  • Participants with renal impairment, Part 1 only:
  • Reduced renal function based on estimated creatinine clearance at the Screening visit. Creatinine clearance can be estimated from serum creatinine concentration at the Screening visit using the Cockcroft-Gault equation, or be a historical measured value obtained within the preceding 3 months. Participants with severe, moderate or mild renal impairment must have creatinine clearance of less than or equal to (<=) 29, 30 to 59, or 60 to 89 mL/min, respectively
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  • Stable renal function. The stability of renal function will be confirmed by two determinations of serum creatinine separated by at least 7 days (one of which can be a historical value within the last 3 months). Renal function will be considered stable if the 2 serum creatinine values differ by <=30 percent (%) of the lower value
  • Participants with end-stage renal disease in Part 2 only:
  • Reduced renal function with a clinical diagnosis of end-stage renal disease requiring renal replacement therapy
  • Receiving hemodialysis for more than 3 months at the time of the Screening visit

Who cannot join

  • Recipient of a renal transplant (Part 1 only)
  • Presence of renal carcinoma, or acute renal disease caused by infection or drug toxicity
  • Nephrotic syndrome (defined as plasma albumin less than [<] 3 grams per deciliter [g/dL] and/or proteinuria greater than [>] 3 grams per day [g/day])
  • Hemoglobin concentration <10 g/dL, or <9 g/dL for participants with end-stage renal disease
  • Potassium concentration >5.5 millimoles per liter (mmol/L)
  • Clinically significant liver disease
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  • Uncontrolled blood pressure
  • Any condition associated with intra-vascular volume depletion
  • Any unstable clinically significant disease
  • Any other ongoing condition or disease (apart from renal dysfunction), or clinically significant abnormalities in laboratory test results that the investigator considers would render the participant unsuitable for the study, place the participant at undue risk or interfere with the ability of the participant to complete the study
  • Major surgery or significant traumatic injury <28 days prior to the first administration (excluding biopsies), or anticipation of the need for major surgery during study treatment
  • Recent history of alcoholism, drug abuse, or addiction within the last year prior to screening
  • Positive test at Screening of any of the following: Hepatitis A, Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV)
  • Clinically significant change in disease status as judged by the investigator, or any major illness within the 4 weeks prior to the Screening visit, or febrile illness within 14 days prior to the Screening visit
  • Use of prohibited medications, or alteration to a concomitant medication treatment regimen considered relevant by the investigator within 14 days before the Screening visit
  • Known history of clinically significant hypersensitivity or severe allergic reaction to any drug, in particular antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams)
  • Participation in another clinical study with an investigational drug or device within the 1 month preceding the Screening vist
  • Donation or loss of over 500 milliliters (mL) of blood within the 3 months before the Screening visit

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • New Orleans Center for Clinical Research

    Knoxville, Tennessee, 37920

  • Clinical Pharmacology of Miami, Inc.

    Miami, Florida, 33014

  • DaVita Clinical Research

    Minneapolis, Minnesota, 55404

  • Orlando Clinical Research Center

    Orlando, Florida, 32809

  • Prism Clinical Research

    Saint Paul, Minnesota, 55114

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label, Two-Part Study to Investigate the Effect of Renal Function and Hemodialysis on the Pharmacokinetics of RO7079901

This is a multi-center, non-randomized, open-label, two-part study to investigate the effect of renal function and hemodialysis on PK of RO7079901. Part 1 will be conducted in adult male and female participants with stable mild, moderate or severe renal impairment and a control group of participants with normal renal function. Part 2 will be conducted in adult male and female participants with stable end-stage renal disease undergoing hemodialysis.

Being tested
RO7079901
Medical subject headings
Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO7079901Drug

    Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.

Study groups in NCT02975388
Study groupRoleWhat they receive
Label: RO7079901 (Mild) (Part 1)ExperimentalParticipants with mild renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Receives: Drug: RO7079901
RO7079901 (Moderate) (Part 1)ExperimentalParticipants with moderate renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Receives: Drug: RO7079901
RO7079901 (Severe) (Part 1)ExperimentalParticipants with severe renal impairment (but not undergoing hemodialysis) will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Receives: Drug: RO7079901
RO7079901 (Normal) (Part 1)Active comparatorControl group of participants with normal renal function will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Receives: Drug: RO7079901
RO7079901 (End-stage) (Part 2)ExperimentalParticipants with stable end-stage renal disease undergoing hemodialysis will be enrolled in this arm. Participants will receive the specified dose of RO7079901.
Receives: Drug: RO7079901

What is being measured

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

  1. Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data

    Measured: Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  2. Volume of Distribution of the Central Compartment (Vc) of RO7079901 Using Plasma Concentration Data

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  3. Total Volume of Distribution (Vz) of RO7079901 Using Plasma Concentration Data

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  4. Volume of Distribution at Steady-State (Vss) of RO7079901 Using Plasma Concentration Data

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  5. Renal Clearance (CLr) of RO7079901

    Measured: Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose ( infusion length: 0.5 hr)

  6. Part 2: Dialysis Clearance (CLd) of RO7079901

    Measured: Dialyzer input, output blood and dialyzer fluid: 1.5 hours postdose (start of hemodialysis); 2.5, 3.5, 4.5 hours postdose (end of hemodialysis) (infusion length: 0.5 hr)

  7. Measured Creatinine Clearance (mCLcr)

    Measured: Blood and Urine: Day -1 ( over the 24-hr period predose corresponding to time of micturition), Day 1 ( Part 1)

  8. Estimated Creatinine Clearance Using the Cockcroft and Gault Formula (eCLcr[CG])

    Measured: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)

  9. Estimated Creatinine Clearance Using the Modified Jelliffe Formula (eCLcr[Jelliffe])

    Measured: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)

  10. Estimated Glomerular Filtration Rate (eGFR) Using the Modification of Diet in Renal Disease (MDRD) Formula (eGFR[MDRD])

    Measured: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)

  11. eGFR Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Formula (eGFR[CKD-EPI])

    Measured: Blood and Urine: Day -1 (over the 24-hr period predose corresponding to time of micturition), Day 1 (Part 1)

Secondary outcomes (7)

  1. Area Under the Plasma Concentration-Time Curve From Time 0 to infinity (AUC0-inf) of RO7079901

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  2. Maximum Plasma Concentration (Cmax) of RO7079901

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  3. Time to Reach Cmax (tmax) of RO7079901

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  4. Terminal Elimination Half-life (t1/2) of RO7079901

    Measured: Blood: Part 1 - Predose (-1 to 0 hr), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)

  5. Cumulative Amount Excreted in Urine (Ae) of RO7079901

    Measured: Urine: Part 1 - 0-4, 4-8, 8-12, 12-24 hr postdose; Part 2 - 0-12 hr postdose (infusion length: 0.5 hr)

  6. Fraction Excreted in Urine (Fe) of RO7079901

    Measured: Blood:Predose (-1 to 0hr), 0.5, 1, 1.5, 8, 12, 24 hr postdose(Parts 1 and 2); 2, 3, 4, 6 hr postdose(Part 1); 4.5 hr postdose(end of hemodialysis)(Part 2); Urine:0-4, 4-8, 8-12, 12-24 hr postdose(Part 1); 0-12 hr postdose(Part 2)(infusion length: 0.5 hr)

  7. Percentage of Participants with Adverse Events (AEs)

    Measured: Baseline up to end of the study (up to approximately 7 months)

Timeline

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

  1. First posted29 Nov 2016 (estimated)
  2. Study start20 Dec 2016
  3. Primary completion6 Jul 2017
  4. Study completion6 Jul 2017

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
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975388
Sponsor's protocol ID
NP39380
Status last verified
Dec 2017
First submitted
24 Nov 2016
Last updated
11 Dec 2017
Results posted
No

Publications

  • Morita J, Ishiwata K, Matsumoto S, Rodriguez I, Patel K, Attley G, Mallalieu NL, Bentley D. A multi-center, open-label, two-part study to investigate the effect of renal function and hemodialysis on the pharmacokinetics of the novel beta-lactamase inhibitor nacubactam. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0011326. doi: 10.1128/aac.00113-26. Epub 2026 Apr 30.

    PubMed 42059789

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO7079901 in people with Renal Impairment, run by Hoffmann-La Roche at 5 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 10 inclusion and 18 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 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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.

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?

Total Body Clearance (CL) of RO7079901 Using Plasma Concentration Data (time frame: Blood: Part 1 - Predose (-1 to 0 hour [hr]), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, and 24 hr postdose; Part 2 - Predose (-1 to 0 hr), 0.5, 1, 1.5 (start of hemodialysis), 4.5 (end of hemodialysis), 8, 12, and 24 hr postdose (infusion length: 0.5 hr)). The study lists 11 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 NCT02975388, which also lists 1 linked publication.

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 11 Dec 2017.

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