Effects of PH3 in Diabetic Nephropathy (PH3)

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathy
• Intervention / Treatment: Drug: PH3

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and Females between 18 and 70 years of age with type 1 or type 2 diabetes
2. Sitting blood pressure of <=140/90 mm Hg
3. Serum creatinine <=2.0 mg/dL
4. Urinary albumin: creatinine ratio between 30 mg/g to 1000 mg/g creatinine (of the first urine sample of the day)
5. Hemoglobin A1c <=8%
6. 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
7. Voluntary written consent to participate in this study

Exclusion Criteria:

1. History of major cardiovascular or cerebrovascular events within 6 months prior to screening
2. History of cancer
3. Receiving chronic nonsteroidal anti-inflammatory therapy
4. History of diabetic ketoacidosis
5. 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
6. Has participated in other investigational trials within 28 days prior to study enrollment
7. Has taken herbal medical treatment as prescription medication and/or over-the- counter medication, within 28 days prior to study enrollment.
8. Has known allergy to the study drug

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PhytoHealth Corporation
• Investigators: Principal Investigator: Wu Chang Yang, MD, Taipei Veterans General Hospital, Taiwan; Principal Investigator: Yi-Jen Hung, MD, Tri-Service General Hospital; Principal Investigator: Huey-Herng Sheu, MD, PhD, Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Estimate): November 4, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: PH-CP016