Effects of PH3 in Diabetic Nephropathy

Study Overview
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Brief Summary
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The primary objective of this clinical study is to evaluate the effectiveness and safety of PH3 for patients with diabetic nephropathy. The secondary objectives are to identify the optimal dosage for subsequent studies and to provide basis for the next confirmatory study in study design, endpoints, and study methodologies.

Official Title
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Effects of PH3 in Diabetic Nephropathy

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: PH3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes Sitting blood pressure of <=140/90 mm Hg Serum creatinine <=2.0 mg/dL Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day) Hemoglobin A1c <=8% Women of child-bearing potential must test negative in a pregnancy test and take contraception measures to prevent pregnancy and can not be breast-feeding Voluntary written consent to participate in this study Exclusion Criteria: History of major cardiovascular or cerebrovascular events within 6 months prior to screening History of cancer Receiving chronic nonsteroidal anti-inflammatory therapy History of diabetic ketoacidosis Has clinically significant deviation from normal physical examination findings that, in the principal investigator's judgment, may interfere with the study evaluation or affect subject safety Has participated in other investigational trials within 28 days prior to study enrollment Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment. Has known allergy to the study drug

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Placebo | Drug: PH3<br>* Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.<br>|
| Active Comparator: B<br>250mg active ingredient | Drug: PH3<br>* Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.<br>|
| Active Comparator: C<br>500mg active ingredient | Drug: PH3<br>* Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.<br>|
| Active Comparator: D<br>1000mg active ingredient | Drug: PH3<br>* Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary Albumin/Creatinine Ratio (UACR) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Albumin Serum Creatinine and the estimated GFR (glomerular filtration rate) HbA1c |  | 24 weeks |