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Prolonged improvement of renal function comprising infrequent administration of an AAIRA

A technology for renal function and use, applied in the field of prolonged improvement of renal function including low-frequency administration of AA1RA, which can solve problems such as increased cardiac workload, difficulty in effective treatment, arrhythmia, and cardiovascular system

Inactive Publication Date: 2009-06-24
NOVACARDIA INC (US)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Worsening renal function makes effective treatment with standard diuretics more difficult, may increase cardiac workload, trigger cardiac arrhythmias, and lead to production of chemicals that may adversely affect the cardiovascular system

Method used

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  • Prolonged improvement of renal function comprising infrequent administration of an AAIRA
  • Prolonged improvement of renal function comprising infrequent administration of an AAIRA
  • Prolonged improvement of renal function comprising infrequent administration of an AAIRA

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0116] Example 1: Pharmacokinetic study of KW-3902

[0117] Subjects received a single intravenous dose of 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg of KW-3902 as indicated. Serum concentrations of KW-3902 and its M1-anti-metabolite were measured using routine analytical methods. Pharmacokinetic values ​​are determined using conventional mathematical formulas. Data are presented in Table 1.

[0118] Table 1

[0119]

[0120]

[0121] T of 30mg dose of KW-3902 1 / 2 The average is 14.7 hours.

[0122] These data were extrapolated to generate curves showing simulated serum concentrations of KW-3902 and M1-trans following intravenous infusion of KW-3902. Curves for simulated concentrations are shown in Figures 1A and 1B. Briefly, both 1A and 1B demonstrate the predicted serum concentrations of KW-3902 and M1-reverse over time following a single 25 mg or 30 mg intravenous dose of KW-3902. As indicated in the legend, the curves show predicted conce...

example 2

[0124] Example 2: Treatment of Individuals with Stable CHF

[0125] A double-blind, multicentre, cross-over design controlled study was performed as follows: approximately 23 individual outpatients were randomized into groups. Subject has an estimated creatinine clearance between 30 mL / min and 80 mL / min and is taking >80 mg of furosemide daily. Subjects receive at least two treatments separated by at least 3 days, wherein the median interval between treatments is 6 days. In addition to receiving 80 mg intravenous furosemide over 120 minutes, each patient received 30 mg intravenous KW-3902 or placebo over 120 minutes. Patients who received KW-3902 at the first visit received placebo at the second visit and vice versa. Neodiatrizoate (Iothalamate) (CONRAY TM ) and p-aminohippurate infusion, the corresponding assessment of glomerular filtration rate (GFR) and renal plasma flow (RPF). Neodiatrizoate and p-aminohippuprate were administered 180 minutes prior to KW-3902 / placebo...

example 3

[0132] Example 3: KW-3902 improves renal function in CHF patients refractory to standard diuretic therapy Function

[0133] A double-blind placebo-controlled study was performed as follows: 35 individuals with congestive heart failure refractory to standard diuretic therapy were identified. Subjects were randomized and divided into four treatment groups: (1) placebo (n=11); (2) 10 mg KW-3902 (n=8); (3) 30 mg KW-3902 (n=7); and (4 ) 60 mg KW-3902 (n=7). Discontinue the patient's diuretic therapy at least 5 hours prior to treatment. Beginning at -3 hours, urine was collected for volume and creatinine clearance measurements. At 0 hours, patients were given an intravenous infusion of KW-3902 or placebo along with the patient's current diuretic regimen. Blood and urine samples were collected at 0, 3, 6, 9, 12, and 24 hours after study drug administration. The change in creatinine clearance (mL / min) from baseline at 0-3 hours, 3-6 hours, 6-9 hours, 9-12 hours, and 12-24 hour...

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Abstract

A method for treating a patient, comprising providing a therapeutically-effective amount of an AA1RA to the patient; and informing the patient or a medical care worker that administration of the AA1RA can provide an improvement in renal function that persists for a time period following administration of the AA1RA, and wherein the time period is at least 3 days.

Description

[0001] Related applications [0002] This application claims to be filed June 16, 2006 by Dittrich et al. and is entitled "PROLONGED IMPROVEMENT OF RENAL FUNCTION COMPRISINGINFREQUENT ADMINISTRATION OF AN AA 1 RA", the entire disclosure of which is incorporated herein by reference in its entirety. technical field [0003] Embodiments disclosed herein relate to methods of protracted improvement of renal function in a subject in need of maintaining, restoring or improving renal function. Background technique [0004] Physicians increasingly recognize the important relationship between the heart and kidneys in congestive heart failure (CHF). This complex interaction is called the cardio-renal syndrome. Multiple studies have demonstrated that renal dysfunction is a strong independent predictor of worse short-term and long-term outcomes in patients with CHF. For example, during hospitalization, an increase in serum creatinine of more than 0.3 mg / dL, a commonly used indicator ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/522A61P9/04A61P13/12
CPCA61K31/522A61P9/04A61P13/12
Inventor 霍华德·迪特里奇布莱恩·法默兰迪·伍兹
Owner NOVACARDIA INC (US)
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