A clinical pharmacology study of TMX-049 in subjects with normal renal function or impaired renal function.
- Conditions
- Subjects with normal renal function and patients with impaired renal function.
- Registration Number
- JPRN-jRCT2080224863
- Lead Sponsor
- Teijin Pharma Limited
- Brief Summary
Plasma exposure of TMX-049 tended to increase in patients with severe renal impairment compared to those with normal renal function, but no clear difference was observed in patients with moderate renal impairment. In both severe and moderate renal impairment groups, changes from baseline in serum uric acid levels after the TMX-049 administration were smaller than those in the normal renal function group. No specific safety concerns were identified in any of the groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 24
Estimated eGFR(mL/min/1.73 m2) * within the categories shown below
1)Severe renal impairment: 10 =< eGFR < 30
2)Moderate renal impairment: 30 =< eGFR < 60
3)Normal renal function: 90 =< eGFR
*: calculated using the eGFRcreat Formula
-Serum urate => 5.0 mg/dL
etc
-Patients who have gouty arthritis
-Patients who have malignant tumor
-Patients who have severe hepatic insufficiency
-Patients who have poor blood pressure control
-Patients who have poor glycaemic control
etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method