A Phase 2a, Single-Center Study Investigating the Short-Term Renal Hemodynamic Effects, Safety and Pharmacokinetics/ Pharmacodynamics of Oral Tolvaptan in Subjects with Autosomal Dominant Polycystic Kidney Disease at Various Stages of Renal Functio

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 36

Inclusion Criteria

This study will be started in subjects with eGFR >30 mL/min*1.73m2. Other important inclusion criteria are: confirmed diagnosis of ADPKD, body mass index of <35 kg/m2, in good health determined by: medical history, physical examination, ECG, serum/urine biochemistry, hematology tests. See protocol page 29.
Following determination of the effects in patients with eGFR >30 mL/min*1.73m2, subjects with eGFR <30 mL/min*1.73m2 will be entered as appropriate. If necessary, subjects withdrawn from the trial will be replaced.

Exclusion Criteria

- Subjects with previous exposure to tolvaptan
- Subjects with recent (within last 6 months) renal surgery
- Subjects with evidence of renal cystic disease other than ADPKD (e.g. renal cancer)
- Safety contraindications including: reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure as tolvaptan, significant risk factors for renal impairment other than ADPKD (e.g. advanced diabetes), a history of significant coagulation defects, critical electrolyte inbalances, low blood volume, clinically significant anemia, history of substance abuse, uncontrolled hypertension.
- Contraindications to or interference with MRI assessments
See protocol page 30 for further details.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>GFR as determined by iothalamate clearance, ERPF as determined by hippuran<br /><br>clearance and filtration fraction (GFR/ERPF).</p><br>

Secondary Outcome Measures

Name	Time	Method

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