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| Name | Class |
|---|---|
| Clinartis | INDUSTRY |
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This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and female subjects with normal and impaired renal function. The study will be composed of five groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal impairment, end stage renal disease patients on hemodialysis (6 patients) and their respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEP-TAZ | Experimental | Cefepime and Tazobactam combination; IV infusion over a period of 90 minutes Healthy subjects, Mild and Moderate RI: 4 g (2 g FEP and 2 g TAZ) Severe RI and patients on HD: 2 g (1 g FEP and 1 g TAZ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefepime and Tazobactam combination | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentrations (Cmax) | 48 hrs | |
| Tmax The elimination half-life (t1/2), | 48 hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | 14 days | |
| Number of Participants With Adverse Events | 14 days |
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Inclusion Criteria:
-Patients with renal impairment: mild, moderate, severe and patients on hemodialysis) that has been stable OR
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami,Division of Clinical Pharmacology | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31332068 | Derived | Preston RA, Mamikonyan G, Mastim M, Garg D, Kemper CJ, Xu A, Yeole R, Chavan R, Friedland HD, Bhatia A. Single-Center Investigation of the Pharmacokinetics of WCK 4282 (Cefepime-Tazobactam Combination) in Renal Impairment. Antimicrob Agents Chemother. 2019 Sep 23;63(10):e00873-19. doi: 10.1128/AAC.00873-19. Print 2019 Oct. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077723 | Cefepime |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |