Phase 2 N=29 Treatment

Short-term Renal Hemodynamic Effects of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Autosomal Dominant Polycystic Kidney Disease

Bottom Line

View on ClinicalTrials.gov: NCT01336972 ↗

Enrolled (actual)

Serious AEs

6.9%

Results posted

Jun 2017

Primary outcome: Primary: Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment. — -8.0; -6.2; -0.7; 0.1 mL/min — p=<0.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Tolvaptan (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.	-8.0; -6.2; -0.7; 0.1; -1.5; -1.2	<0.05 sig
PRIMARY Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.	-16.9; -11.1; -1.7; 4.3; -8.4; -1.3	>0.05
PRIMARY Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.	-0.005; -0.013; -0.010; -0.003; 0.005; -0.016	>0.05
SECONDARY Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment	4.334; 2.822; 1.701; -0.675; -0.195; 0.382	<0.05 sig
SECONDARY Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.	828; 591; 840	—
SECONDARY Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.	2.0; 2.0; 2.0	—
SECONDARY Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.	2850; 2140; 3100	—
SECONDARY Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.	-4.5; -4.6; -1.9; -1.5; -2.4; -0.7	<0.05 sig
SECONDARY Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.	4551.1; 3274.4; 2215.0; -312.2; -287.2; 143.1	<0.05 sig
SECONDARY Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.	888.9; 625.6; 356.7; -187.8; -10.0; 27.5	<0.05 sig

Summary

The purpose of the trial was to determine the short-term effects of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) at various levels of renal function.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01336972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.