NL-OMON34527
Completed
Phase 2
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 Function - Phase 2a study in adult subjects with ADPKD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Covance
- Enrollment
- 36
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 If necessary, subjects withdrawn from the trial will be replaced.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.
Outcomes
Primary Outcomes
Not specified
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