Autosomal dominant polycystic kidney disease (ADPKD)
Conditions
Interventions
investigational material(s)
Generic name etc : N/A
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : N/A
Sponsors
Otsuka Pharmaceutical Dvelopment & Commercialization, Inc.
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Existing diagnosis of ADPKD by modified-Ravine criteria 2) Total kidney volume >= 300 cc/m height by ultrasound or >= 250 cc/m height by MRI
Exclusion criteria
Exclusion criteria: 1) Current or expected (within the next six months) interventions for the treatment of ADPKD affecting kidney volume
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of change in total kidney volume with ADPKD-related outcomes every 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported pain every 6 months SF-12 Scores every 6 months ADPKD-Impact Scale Scores every 6 months Cost of care every 6 months EuroQuol-5D Scores every 6 months | — |
Outcome results
None listed