Subacute Effect of Tolvaptan on Total Kidney Volume in Adult Patients With Autosomal Dominant Polycystic Kidney Disease

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Investigator initiated controlled multi-centre trial in a Prospective, Randomised, Open, Blinded Endpoint (PROBE) design.

Patients will be randomised in a 1:1 ratio either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medication or no tolvaptan treatment, but following the same visit and investigation plan as the subjects taking tolvaptan.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lisbet Brandi
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Adult patients between 18 and 65 years

• Diagnosis of typical ADPKD

• tKV above or equal to 750 ml by MRI scanning

• Estimated GFR (e-GFR) by CKD-EPI formula of above or equal to 45 mL/min/1.73 m2

Exclusion Criteria:

• Kidney transplant recipient

• Known liver disease except for liver cysts relating to ADPKD

• ASAT and ALAT above upper normal level

• Current treatment with thiazide and thiazide-line diuretics, mineral corticoid receptor antagonists, amiloride or loop diuretics

• Evidence of urinary tract obstruction

• Current treatment with CYP3A4 inhibitors

• Active malignant disease

• Current or previous treatment with tolvaptan