Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Autosomal Dominant Polycystic Kidney Disease
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of autosomal dominant polycystic kidney disease (ADPKD) by Ravine criteria.
Exclusion Criteria:
- Renal replacement therapy.
- Use of therapies for the purpose of affecting polycystic kidney disease (PKD) cysts.
- Evidence of significant renal disease, eg, active glomerular nephritides, renal cancer, single kidney.
- Significant risk-factors for renal impairment, eg, chronic use of diuretics, advanced diabetes, use of nephrotoxic drugs.
- History of significant coagulation defects or hemorrhagic diathesis.
Sites / Locations
- University Medical Center Groningen
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A - eGFR > 60 ml/min/1.73m^2
Group B - eGFR 30 to 60 ml/min/1.73m^2
Group C - eGFR < 30 ml/min/1.73m^2
Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM [8 hours later]) to the maximally tolerated dose.
Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM [8 hours later]) to the maximally tolerated dose.
Participants received tolvaptan for the first 3 weeks of the 6 week study. Participants were up-titrated on a weekly basis from tolvaptan 45/15 mg to 60/30 mg to 90/30 mg oral split-dose (AM and PM [8 hours later]) to the maximally tolerated dose.