Effects of PH3 in Diabetic Nephropathy (NCT01068041) | Clinical Trial Compass
CompletedPhase 2
Effects of PH3 in Diabetic Nephropathy
Taiwan100 participantsStarted 2010-08
Plain-language 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 methodologies.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.