A Phase 1b/2a, Safety, Pharmacokinetic and Dose-Escalation Study of KD019 in Subjects With Autosomal Dominant Polycystic Kidney Disease
Location:
Rochester, MN.
Trial status:
Open for Enrollment
Why is this study being done?
Phase 1:
- Primary purpose is to determine the safety of KD019.
- 28-days, daily dosing study with option to continue through six months of KD019 dosing.
- All participants receive active KD019 study drug.
- KD019 is an oral once daily tablet. Tablets are 50 mg in strength. Participants will enroll into three sequential dosing cohort levels (50 mg, 100 mg and 150 mg.
- Study participants will have MRI of the abdomen (kidneys) at Screening and Month 6 visit to explore effects of KD019.
- Echocardiogram will be performed at Screening, Day 28, and Months 2-6 if option for continuation past Day 28 is accepted.
Phase 2:
- Primary purpose is to compare the annualized change in glomerular filtration rate (GFR) in subjects with ADPKD when treated with KD019.
- Dosing is 28-days of daily. Subjects may, if they desire and at the discretion of the investigator, continue to receive study treatment for 12 months from their first dose or until the development of unacceptable toxicity, noncompliance, or withdrawal of consent by the subject, or investigator decision.
- All participants receive active KD019 study drug.
- KD019 is an oral once daily tablet. Tablets are 50 mg in strength. Participants in Phase 2 will be given the maximum tolerated dose.
- Study participants will have MRI of the abdomen (kidneys) at Screening and Month 6 visit and every 6 months after to explore effects of KD019.
- Echocardiogram will be performed at Screening, Day 28, and Months 2-6 if option for continuation past Day 28 is accepted.
Who is eligible to participate?
Inclusion Criteria:
- The subject has a confirmed diagnosis of ADPKD.
- The subject has a GFR ≥ 50 mL/min/1.73 m2.
- Cysts must be at least 1 cm in size.
- Adequate bone marrow, kidney, and liver function.
Exclusion Criteria:
- The subject has had a previous partial or total nephrectomy.
- The subject has tuberous sclerosis, Hippel-Lindau disease, or acquired cystic disease.
- The subject has congenital absence of one kidney and/or need for dialysis.
- Presence of renal or hepatic calculi (stones) causing symptoms.
- The subject has received any investigational therapy within 30 days prior to study entry.
- Active treatment (within 4 weeks of study entry) for urinary tract infection.
Last updated:
7/15/2013
NCT ID:
NCT01559363