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Grazoprevir (MK-5172) and Elbasvir (MK-8742) were studied as the principal components of combination oral therapy for hepatitis C virus (HCV). The study examined the pharmacokinetic (PK) profiles of Grazoprevir and Elbasvir following 10 days of dosing in participants with end stage renal disease (ESRD) on hemodialysis (HD) or participants with severe renal impairment. Both groups were compared to healthy matched controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with End Stage Renal Disease on Hemodialysis | Experimental | Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.. |
|
| Participants with Severe Renal Impairment | Experimental | Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
|
| Healthy Participants | Experimental | Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grazoprevir | Drug | 100 mg oral tablet administered once a day for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | Up to 24 hours postdose |
| Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | Up to 120 hours postdose |
| Time of Maximum Plasma Concentration (Tmax) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | Up to 120 hours postdose |
| Apparent Terminal Half-life (T1/2) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 | Up to 120 hours postdose |
| Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir |
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Inclusion Criteria:
All Participants
Exclusion Criteria:
All Participants
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30680407 | Result | Caro L, Wenning L, Feng HP, Guo Z, Du L, Bhagunde P, Fandozzi C, Panebianco D, Marshall WL, Butterton JR, Iwamoto M, Yeh WW. Pharmacokinetics of elbasvir and grazoprevir in subjects with end-stage renal disease or severe renal impairment. Eur J Clin Pharmacol. 2019 May;75(5):665-675. doi: 10.1007/s00228-018-2585-3. Epub 2019 Jan 25. |
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After enrollment of participants with End Stage Renal Disease and Severe Renal Impairment, healthy participants with matching mean age, body mass index, and gender were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With End Stage Renal Disease on Hemodialysis | Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| FG001 | Participants With Severe Renal Impairment | Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| FG002 | Healthy Participants | Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With End Stage Renal Disease on Hemodialysis | Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| BG001 | Participants With Severe Renal Impairment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM*hr | Up to 24 hours postdose |
|
Up to 14 days after the last dose of study drug (up to 24 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With End Stage Renal Disease on Hemodialysis | Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme, Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C578009 | grazoprevir |
| C000589335 | elbasvir |
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| Elbasvir | Drug | 50 mg oral tablet administered once a day for 10 days |
|
Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) |
| Up to 24 hours postdose |
| Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 | Up to 24 hours postdose |
| Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | Up to 24 hours postdose |
| Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir | Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | 24 hours postdose |
| Maximum Plasma Concentration (Cmax) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | Up to 120 hours postdose |
| Time of Maximum Plasma Concentration (Tmax) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | Up to 120 hours postdose |
| Apparent Terminal Half-life (T1/2) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 | Up to 120 hours postdose |
| Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | Up to 24 hours postdose |
| Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 | Up to 24 hours postdose |
Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| BG002 | Healthy Participants | Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Estimated Glomerular Filtration Rate | Glomerular Filtration Rate at baseline was based on the Modification of Diet Renal Disease equation. N=6 instead of 8 for Healthy Participants. | Mean | Full Range | mL/min/1.73 m^2 |
|
| OG001 | Participants With Severe Renal Impairment: Day 10 | Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
| OG002 | Healthy Participants: Day 10 | Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. |
|
|
|
| Primary | Plasma Concentration at 24 Hours Postdose (C24hr) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | nM | 24 hours postdose |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM | Up to 120 hours postdose |
|
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | Hours | Up to 120 hours postdose |
|
|
|
| Primary | Apparent Terminal Half-life (T1/2) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Up to 120 hours postdose |
|
|
|
| Primary | Apparent Clearance After Extravascular Administration (CL/F) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | Liters/hr | Up to 24 hours postdose |
|
|
|
|
| Primary | Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Grazoprevir | Blood for determination of Grazoprevir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day. | Posted | Geometric Mean | 95% Confidence Interval | Liters | Up to 24 hours postdose |
|
|
|
|
| Primary | Area Under the Concentration-time Curve From 0 to 24 Hours Postdose (AUC0-24hr) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM*hr | Up to 24 hours postdose |
|
|
|
|
| Primary | Plasma Concentration at 24 Hours Postdose (C24hr) of Elbasvir | Blood for determination of Elbasvir concentration was collected at 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | nM | 24 hours postdose |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | uM | Up to 120 hours postdose |
|
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 (all participants) and only up to 24 hours for ESRD participants on Day 9 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Median | Full Range | Hours | Up to 120 hours postdose |
|
|
|
| Primary | Apparent Terminal Half-life (T1/2) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, 24, 32, 48, 72, 96, and 120 hours postdose on Day 10 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day. | Posted | Geometric Mean | Geometric Coefficient of Variation | Hours | Up to 120 hours postdose |
|
|
|
| Primary | Apparent Clearance After Extravascular Administration (CL/F) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 9 (ESRD participants only) or Day 10 (all participants) | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. | Posted | Geometric Mean | 95% Confidence Interval | Liters/hr | Up to 24 hours postdose |
|
|
|
|
| Primary | Apparent Volume of Distribution After Extravascular Administration (Vz/F) of Elbasvir | Blood for determination of Elbasvir concentration was collected predose and 0.5, 1, 2, 3, 4, 5, 5.5, 6, 7, 8, 12, 16, and 24 hours postdose on Day 10 | The Per Protocol population included all participants who complied with the protocol sufficiently to ensure that these data likely to exhibit the effects of treatment, according to the underlying scientific model. End Stage Renal Disease for Non-HD Day 9 was not reported since only 24-hour collections were made on that day. | Posted | Geometric Mean | 95% Confidence Interval | Liters | Up to 24 hours postdose |
|
|
|
|
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Participants With Severe Renal Impairment | Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. | 0 | 8 | 3 | 8 |
| EG002 | Healthy Participants | Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. | 0 | 8 | 3 | 8 |
| Nausea | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA version 16.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.1 | Systematic Assessment |
|
The sponsor will provide separate guidance on the criteria for publication of clinical trial data when contacted for permission to publish.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Day 10 |
|
| Geometric Mean Ratio |
| 0.79 |
| 2-Sided |
| 90 |
| 0.54 |
| 1.16 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.78 | 2-Sided | 90 | 0.53 | 1.14 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.60 | 2-Sided | 90 | 1.06 | 2.42 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Day 10 |
|
| Geometric Mean Ratio |
| 0.92 |
| 2-Sided |
| 90 |
| 0.57 |
| 1.48 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.88 | 2-Sided | 90 | 0.54 | 1.42 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.66 | 2-Sided | 90 | 0.99 | 2.77 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Day 10 |
|
| Day 10 |
|
| Geometric Mean Ratio |
| 1.18 |
| 2-Sided |
| 90 |
| 0.80 |
| 1.73 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.21 | 2-Sided | 90 | 0.82 | 1.78 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.61 | 2-Sided | 90 | 0.40 | 0.92 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Geometric Mean Ratio |
| 0.61 |
| 2-Sided |
| 90 |
| 0.39 |
| 0.94 |
Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 |
| Superiority or Other |
| Day 10 |
|
| Geometric Mean Ratio |
| 0.86 |
| 2-Sided |
| 90 |
| 0.65 |
| 1.14 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.99 | 2-Sided | 90 | 0.75 | 1.30 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.86 | 2-Sided | 90 | 1.38 | 2.51 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Day 10 |
|
| Geometric Mean Ratio |
| 0.77 |
| 2-Sided |
| 90 |
| 0.56 |
| 1.06 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.95 | 2-Sided | 90 | 0.69 | 1.32 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 2.07 | 2-Sided | 90 | 1.46 | 2.93 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Day 10 |
|
| Geometric Mean Ratio |
| 0.84 |
| 2-Sided |
| 90 |
| 0.62 |
| 1.13 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.94 | 2-Sided | 90 | 0.70 | 1.27 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.66 | 2-Sided | 90 | 1.21 | 2.28 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Day 10 |
|
| Day 10 |
|
| Geometric Mean Ratio |
| 1.16 |
| 2-Sided |
| 90 |
| 0.88 |
| 1.53 |
Geometric Mean Ratio = ESRD Non-HD Day 9 / Healthy Day 10 |
| Superiority or Other |
| ESRD HD Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 1.01 | 2-Sided | 90 | 0.77 | 1.34 | Geometric Mean Ratio = ESRD HD Day 10 / Healthy Day 10 | Superiority or Other |
| SRI Participants Day 10 versus Healthy Participants Day 10 | Geometric Mean Ratio | 0.54 | 2-Sided | 90 | 0.40 | 0.72 | Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 | Superiority or Other |
| Geometric Mean Ratio |
| 0.63 |
| 2-Sided |
| 90 |
| 0.45 |
| 0.89 |
Geometric Mean Ratio = SRI Day 10 / Healthy Day 10 |
| Superiority or Other |