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

NCT03596957 | Unknown Phase 4

• 1 other identifier: PoCKET
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney

Outcome Measures

Primary Outcomes (1)

• Change in total Kidney Volume (tKV) measured by MRI scanning

  The change in the total Kidney Volume after six and 12 weeks participation in the trial

  Between baseline and six weeks and between six and 12 weeks

Secondary Outcomes (6)

• Changes in GFR

  Between baseline and six weeks and between baseline and 12 weeks

• Changes in relevant genetic and non-genetic biomarkers associated with CKD and ESRD

  Between baseline and six weeks and between baseline and 12 weeks

• Changes in Quality of Life

  Between baseline and six weeks and between baseline and 12 weeks

• Subject estimation of own health

  Between baseline and six weeks and between baseline and 12 weeks

• Changes in ASAT and ALAT

  Between baseline and six weeks and between baseline and 12 weeks

Study Arms (2)

Tolvaptan group

ACTIVE COMPARATOR

Treatment with tolvaptan for six weeks followed by six weeks observation without trial medication

Drug: Tolvaptan

Control group

NO INTERVENTION

No tolvaptan treatment but following the same visit and investigation plan as the subjects in the tolvaptan group

Interventions

Tolvaptan DRUG

At baseline the tolvaptan dosing will start with daily morning and afternoon doses of 45 mg and 15 mg respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg according to subject tolerability

Also known as: Jinarc

Tolvaptan group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lisbet Brandi: lead

Study Sites (6)

Aarhus University Hospital - Site 43

Skejby, Aarhus N, 8200, Denmark

RECRUITING

Odense University Hospital - Site 45

Odense, Odense C, 5000, Denmark

NOT YET RECRUITING

Rigshospitalet - Site 42

Copenhagen, 2100, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Nordsjaellands Hospital - Site 41

Hillerød, 3400, Denmark

RECRUITING

Sjællands University Hospital Roskilde

Roskilde, 4000, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Lisbet Brandi, MD DMSc MHM

  KNEA, Nordsjaellands Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisbet Brandi, MD DMSc MHM

CONTACT

+45 48295993; lisbet.brandi@regionh.dk

Clinical Project Manager

CONTACT

+45 48294714; charlotte.bjernved.nielsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The endpoint blinding will be assured since all the MRI scans will be forwarded to the Comparative Medicine Laboratory in Aarhus for evaluation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Department for Endrocrinology and Nephrology, MD, DMSc, MHM

Model Details: Patients will be randomised in a 1:1 ration either to treatment with tolvaptan for six weeks followed by six weeks observation without trial medicaion or to the Control group receiving no tolvaptan treatment for 12 weeks

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: July 24, 2018
• Study Start: September 12, 2018
• Primary Completion: June 1, 2019
• Study Completion: April 1, 2020
• Last Updated: November 26, 2018

Record last verified: 2018-11

Locations

DK (6)