Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00413777
• Date of registration: 18/12/2006
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Public title: Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) TEMPO 2:4
• Scientific title: A Phase 2, Multi-center, Open-label Study to Determine Long-term Safety, Tolerability and Efficacy of Split-dose Oral Regimens of Tolvaptan Tablets in a Range of 30 to 120 mg/d in Patients With Autosomal Dominant Polycystic Kidney Disease
• Date of first enrolment: December 2005
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00413777
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Frank Czerweic, MD
• Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.

• Name: Vicente Torres, MD, PhD
• Affiliation: Mayo Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).

- Able to give Informed Consent.

Exclusion Criteria:

- Women who are breast feeding and females of childbearing potential who are not using
acceptable contraceptive methods.

- In the opinion of the study investigator or sponsor may present a safety risk.

- Patients who are unlikely to adequately comply with study procedures.

- Patients who at Day 1 have an estimated glomerular filtration rate (GFR) below 30
mL/min or who anticipate renal-replacement therapy within one year of study entry.

- Patients having contraindications to magnetic resonance imaging (MRI) or gadolinium
contrast will be eligible but will not be able to participate in MRI.

- Patients taking a diuretic within 1 week of enrollment or likely to need diuretic
therapy prior to Month 2.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Polycystic Kidney, Autosomal Dominant

Intervention(s)

Drug: Tolvaptan

Primary Outcome(s)

Safety Assessments Based on Vital Signs, Electrocardiogram (ECG's), Clinical Laboratory Tests, Physical Examinations Are Reported as Adverse Events (AEs) Upon Study Physician Discretion. [Time Frame: AEs were recorded from screening (ICF was signed) until 7-Day follow-up]

Secondary Outcome(s)

Change From Pre-dose Baseline in Renal Function Estimated by GFR- Extension. [Time Frame: Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 12]

Mean Change From Baseline in MAP for Hypertension Assessment- Extension. [Time Frame: Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12]

Mean Change From Baseline in Mean Arterial Pressure (MAP) for Hypertension Assessment. [Time Frame: Baseline to Month 36]

Change From Pre-dose Baseline in Renal Function Estimated by Glomerular Filtration Rate (GFR). [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Abdominal Girth Measurement- Extension. [Time Frame: Baseline to Extension Day 1, Extension Month 12]

Mean Change From Baseline in dBP for Hypertension Assessment- Extension. [Time Frame: Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12]

Mean Change From Baseline in Patient-assessed Renal Pain Scale- Extension. [Time Frame: Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12]

Mean Change From Baseline in sBP for Hypertension Assessment- Extension. [Time Frame: Baseline to Months 2, 6, 9, 12, 16, 20, 24, 28, 32, 36, Extension Day 1, Extension Month 4, Extension Month 8, Extension Month 12]

Percent Change From Baseline in Renal Volume-Extension. [Time Frame: Baseline to Months 2, 12, 24, 36, Extension Day 1, Extension Month 12]

Mean Change From Baseline in Patient-assessed Renal Pain Scale. [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime. [Time Frame: Baseline to Month 24]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose. [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Abdominal Girth Measurement. [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose. [Time Frame: Baseline to Month 24]

Mean Change From Baseline in Diastolic Blood Pressure (dBP) for Hypertension Assessment. [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Systolic Blood Pressure (sBP) for Hypertension Assessment. [Time Frame: Baseline to Month 36]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to First Daily Dose- Extension. [Time Frame: Baseline to Months 2, 6, 12, 24, 36, Extension Day 1, Extension Month 12]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Bedtime- Extension. [Time Frame: Baseline to Month 24]

Mean Change From Baseline in Trough Urine Osmolality at Steady State Prior to Second Daily Dose- Extension. [Time Frame: Baseline to Month 24]

Percent Change From Baseline in Renal Volume. [Time Frame: Baseline to Month 36]

Secondary ID(s)

156-04-250

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Otsuka Pharmaceutical Co., Ltd.

Results

• Results available: Yes
• Date Posted: 02/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00413777