ADPKD autosomal polycystic kidney disease
Conditions
Interventions
None listed
Sponsors
Otsuka America Pharmaceutical
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Ages 12 to 70 years, inclusive (18 to 70 inclusive in the Netherlands) 2. Existing diagnosis of ADPKD by modified-Ravine criteria: • With family history: several cysts per kidney (3 if by sonography, 5 if by computerized tomography or MRI) • Without family history: 10 cysts (by any radiologic method) per kidney and exclusion of other cystic kidney diseases 3. Ability to provide written, informed consent/assent prior to initiation of any study-related procedures, and ability, in the opinion of the investigator, to comply with all requirements of the study. 4. Total kidney volume >= 300 cc/m height by ultrasound (within 1 year prior to baseline) or >= 250 cc/m height by MRI (within 1 year prior to baseline).
Exclusion criteria
Exclusion criteria: 1. Any medical condition, in the opinion of the Investigator, that could interfere with evaluation of the study objectives (eg, inability to comply with MRI) 2. Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume without the prior approval of the sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: • Investigate a correlation between the rate of kidney enlargement and the decline of renal function in ADPKD patients • Establish the utility of renal volume measurements as a prognostic marker of disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: • Evaluate and establish the level of, and associations between, the impact of disease on patient reported outcomes (PROs) for pain, health related quality of life (HRQoL), and ADPKD-associated health burden • Evaluate the impact of disease on medical resource utilization (MRU) and productivity | — |
Countries
Netherlands
Outcome results
None listed