Diabetic NephropathyPhase 2PH3NCT01068041
Effects of PH3 in Diabetic Nephropathy
A Phase 2 study testing PH3 in people with Diabetic Nephropathy, run by PhytoHealth Corporation at 3 sites in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- PH3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesTaiwan
- Study dates
- Aug 2010to Sep 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Taichung Veterans General Hospital
Taichung, 407
Tri-Service General Hospital
Taipei, 114
Taipei Veterans General Hospital
Taipei
About this study
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.
- Conditions
- Diabetic Nephropathy
- Being tested
- PH3
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PH3Drug
Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Placebo Receives: Drug: PH3 |
| B | Active comparator | 250mg active ingredient Receives: Drug: PH3 |
| C | Active comparator | 500mg active ingredient Receives: Drug: PH3 |
| D | Active comparator | 1000mg active ingredient Receives: Drug: PH3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Albumin/Creatinine Ratio (UACR)
Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24
Measured: 24 weeks
Secondary outcomes (4)
Urine Albumin
Change in urine albumin level from baseline to Week 24
Measured: 24 weeks
Serum Creatinine
Change in serum creatinine level from baseline to Week 24
Measured: 24 weeks
Estimated Glomerular Filtration Rate (eGFR)
Change in estimated glomerular filtration rate (eGFR) from baseline to Week 24
Measured: 24 weeks
HbA1c
Change in HbA1c from baseline to Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wu Chang Yang, MD, Principal investigator, Taipei Veterans General Hospital, TaiwanYi-Jen Hung, MD, Principal investigator, Tri-Service General Hospital (TSGH)Huey-Herng Sheu, MD, PhD, Principal investigator, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068041
- Sponsor's protocol ID
- PH-CP016
- Acronym
- PH3
- Status last verified
- Sep 2026
- First submitted
- 11 Feb 2010
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PH3 in Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT01068041
- Acronym / sponsor ID
- PH3 / PH-CP016
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: PH3Placebo |
| B | Active comparator | Drug: PH3250mg active ingredient |
| C | Active comparator | Drug: PH3500mg active ingredient |
| D | Active comparator | Drug: PH31000mg active ingredient |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PH3Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. | Drug | A, B, C, D |
Primary outcome
Urinary Albumin/Creatinine Ratio (UACR)
Time frame: 24 weeks
Change in urinary albumin/creatinine ratio (UACR) from baseline to Week 24
4 secondary outcomes
Urine Albumin
Time frame: 24 weeks
Serum Creatinine
Time frame: 24 weeks
Estimated Glomerular Filtration Rate (eGFR)
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Pentoxifylline in Diabetic Kidney Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wu Chang Yang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
Yi-Jen Hung, MD principal investigator
Tri-Service General Hospital (TSGH)
Huey-Herng Sheu, MD, PhD principal investigator
Taichung Veterans General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PH3 in people with Diabetic Nephropathy, run by PhytoHealth Corporation at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Albumin/Creatinine Ratio (UACR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.