Claims for Patent: 5,662,604

Summary for Patent: 5,662,604

Title:	Monitoring method of renal lesions without clinical signs
Abstract:	A screening method for detecting renal lesions in diabetic patients not yet exhibiting symptoms of nephropathy, comprising administering a predetermined dose of parathyroid hormone, analogue thereof or derivative thereof to the patients with an albumin excretion rate (AER) of microalbumin being below 15 .mu.g/min., measuring urinary excreted N-acetyl-.beta.-D-glucosaminidase (NAG) and urinary creatinine in urinary samples taken 60.+-.10 minutes before and after administration of PTH, and monitoring the increased ratio of urinary excreted NAG (U/g Cr) in post-administration of PTH to the urinary excreted NAG (U/g Cr) in pre-administration of PTH for a value less than 2.3. The screening method provides the possibility of detecting renal lesions without clinical signs of diabetic nephropathy, using a preparation essentially consisting of active ingredient of PTH.
Inventor(s):	Ogata; Etsuro (Tokyo, JP), Kurokawa; Kiyoshi (Tokyo, JP), Uchida; Shunya (Tokyo, JP), Kishida; Akiko (Kanagawa, JP)
Assignee:	Asahi Kasei Kogyo Kabushiki Kaisha (Osaka, JP)
Application Number:	08/495,635
Patent Claims:	1. A screening method for renal lesions in diabetic patients not yet exhibiting symptoms of nephropathy, comprising administering a predetermined dose of a parathyroid hormone, analogue or derivative thereof to the patients, and measuring urinary excreted N-acetyl-.beta.-D-glucosaminidase (NAG). 2. The screening method according to claim 1, wherein the parathyroid hormone is h-PTH (1-34) acetate (teriparatide acetate). 3. The screening method according to claim 2, wherein the teriparatide acetate contains 10-400 teriparatide acetate units. 4. The screening method according to claim 1 wherein the parathyroid hormone is administered intravenously. 5. A screening method for renal lesions in diabetic patients not yet exhibiting symptoms of nephropathy, comprising administering a predetermined dose of parathyroid hormone, analogue or derivative thereof (PTH) to the patients having an albumin excretion rate (AER) less than 15 .mu.g/min., measuring urinary excreted N-acetyl-.beta.-D-glucosaminidase (NAG) and urinary creatinine in urine samples taken 60.+-.10 minutes before and after administration of PTH and monitoring a ratio of urinary excreted NAG-creatinine after administration of PTH to the urinary excreted NAG-creatinine before administration of PTH for a value of less than 2.3. 6. The screening method according to claim 5, wherein a normal range of ratio of the urinary excreted NAG value after administration of PTH to the urinary excreted NAG value before administration of PTH in healthy subjects is 2.4 to 4.7. 7. A method for early detection of renal lesions in diabetic patients not yet exhibiting symptoms of nephropathy, comprising administering a predetermined dose of parathyroid hormone, an analogue or a derivative thereof to said patients, measuring urinary excreted N-acetyl-.beta.-D-glucosaminidase (NAG) after said administration, and comparing an amount of urinary excreted NAG after said administration to an amount of urinary excreted NAG prior to said administration. 8. The method according to claim 7, wherein said patients have an albumin excretion rate (AER) of microalbumin below 15 .mu.h/min.

Details for Patent 5,662,604

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2039-03-29