CompletedPhase 1

Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

United States38 participantsStarted 2008-03

Plain-language summary

The purpose of this study is to evaluate the safety and tolerability of two dosing regimens of FG-3019 administered over 12 weeks in patients with diabetic nephropathy and proteinuria on background angiotensin converting enzyme inhibitor (ACEi) and/or angiotensin II receptor antagonist (ARB) therapy.

Who can participate

Age range

18 Years – 80 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

. Age 18-80 years, inclusive
. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
. First morning urinary ACR \>0.200 g/g
. Receiving stable doses of ACEi and/or ARB therapy prior to Screening
. Estimated glomerular filtration rate of ≥20 and \<90 mL/min/1.73 m2
. Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
. Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization

Questions worth asking your doctor

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.

What they're measuring

Safety and tolerability of FG-3019

Timeframe: 34 weeks

Trial details

NCT IDNCT00754143

SponsorKyntra Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

View on ClinicalTrials.gov More Diabetes Mellitus trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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

. Age 18-80 years, inclusive
. Diagnosis of type 1 or type 2 diabetes according to American Diabetes Association (ADA) criteria
. First morning urinary ACR \>0.200 g/g
. Receiving stable doses of ACEi and/or ARB therapy prior to Screening
. Estimated glomerular filtration rate of ≥20 and \<90 mL/min/1.73 m2
. Willingness to maintain ACEi and/or ARB therapy, and any additional anti-hypertensive therapies to control blood pressure, at a stable dose
. Maintenance of all additional antihypertensive medications, insulin, oral hypoglycemic agents, and cholesterol-lowering medications prior to randomization

Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Phase 1 Study of FG-3019 in Subjects With Type 1 or Type 2 Diabetes Mellitus and Diabetic Nephropathy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria