Summary:
Phase 2 Study - Randomized, Double-Blind Placebo Controlled in patients with
Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM).
Inclusion:
Diagnosis of Chronic Kidney Disease
T1DM or T2 DM (diagnosed > 1 year)
GFR > 30
On a stable anti-diabetic medication regimen for > 4 months with HbA1c < 9.5%
Patient on an ACEi or ARB for > 4 months
UACR > 100 mg/g & < 3000 mg/g
Exclusion:
eGFR < 30
AKI within past 3 months or ever received dialysis
Uncontrolled hypertension systolic > 160 or diastolic > 100
History of major depression within last 2 years
History of hyperthyroidism
This is not a complete list of inclusion and exclusion criteria for this study.
Qualified Participants May Receive:
Qualified Participants:
- You may be provided a meal up to $22 on Week 0/Day 1 and Week 16.
- You may receive up to $52 per visit in reimbursement for travel expenses with required documentation of expenses.
- You will be paid $75.00 for each clinic visit you complete, with the exception of Day 1 and Week 16 in which you will be paid $200.00.
- You will not be paid for telephone visits.
- You will receive payment quarterly.
- The study drug and all tests and procedures required by the study are provided at no cost to you.
- The Sponsor will pay for them.
- The costs of other medications and treatments that you take or use independently of the study are not covered by the Sponsor of this study.