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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT01336972
First received: April 15, 2011
Last updated: May 30, 2017
Last verified: May 2017
Results First Received: March 28, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Autosomal Dominant Polycystic Kidney Disease
Intervention: Drug: Tolvaptan

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The trial was conducted in 29 participants at one center in The Netherlands. Participants were stratified based on their estimated glomerular filtration rate (eGFR): >60, 30-60 and <30 millilitres (mL)/minute (min)/1.73 meter squared (m2). eGFR was assessed using the 4-variable modification of diet in renal disease (MDRD).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The trial consisted of a 2- to 42-day screening period, a 3-week treatment period, and a 3-week post treatment period.

Reporting Groups
  Description
eGFR > 60 mL/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
eGFR 30-60 mL/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
eGFR <30 ml/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.

Participant Flow:   Overall Study
    eGFR > 60 mL/Min/1.73m2   eGFR 30-60 mL/Min/1.73m2   eGFR <30 ml/Min/1.73m2
STARTED   10   10   9 
COMPLETED   9   9   9 
NOT COMPLETED   1   1   0 
Adverse Event                1                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
eGFR > 60 mL/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
eGFR 30-60 mL/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
eGFR <30 mL/Min/1.73m2 Daily split-dose of tolvaptan titrated weekly to the maximally tolerated dose. Starting daily tolvaptan dose of 45mg/15mg titrated to 60mg/30mg, then 90mg/30mg based on tolerability.
Total Total of all reporting groups

Baseline Measures
   eGFR > 60 mL/Min/1.73m2   eGFR 30-60 mL/Min/1.73m2   eGFR <30 mL/Min/1.73m2   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   9   29 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.7  (7.1)   47.8  (12.9)   52.1  (6.7)   46.0  (10.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  60.0%      6  60.0%      2  22.2%      14  48.3% 
Male      4  40.0%      4  40.0%      7  77.8%      15  51.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Measured Glomerular Filtration Rate (mGFR) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: After 3 weeks of treatment and 3 weeks post treatment ]

2.  Primary:   Mean Change From Baseline in Effective Renal Plasma Flow (ERPF) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: After 3 weeks of treatment and 3 weeks post treatment ]

3.  Primary:   Mean Change From Baseline in Filtration Fraction (GFR/ERFP) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: After 3 weeks of treatment and 3 weeks post treatment ]

4.  Secondary:   Mean Change From Baseline in Free Water Clearance After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment   [ Time Frame: After 3 weeks of treatment and 3 weeks post treatment ]

5.  Secondary:   Time to Peak Plasma Concentration (Cmax) After 3 Weeks of Tolvaptan Treatment.   [ Time Frame: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour ]

6.  Secondary:   Time to Peak Plasma Concentration (Tmax) After 3 Weeks of Tolvaptan Treatment.   [ Time Frame: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour ]

7.  Secondary:   Area Under the Concentration-time Curve From 0 to 5 Hours (AUC0-5) After 3 Weeks of Tolvaptan Treatment.   [ Time Frame: Day 0: 0 hour, Day 21: (0, 1, 2, 3, 4 and 5 hours postdose), 3 Weeks after last dose: 0 hour ]

8.  Secondary:   Percentage Change From Baseline in Total Kidney Volume (TKV) After 3 Weeks of Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: After 3 weeks of treatment and 3 weeks post treatment ]

9.  Secondary:   Mean Change From Baseline in 24 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: 24 hours ]

10.  Secondary:   Mean Change From Baseline in 2 Hour Urine Volume After 3 Weeks Tolvaptan Treatment and at 3 Weeks Post Treatment.   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Medical Affairs
Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.
phone: 800 562-3974


Publications:

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01336972     History of Changes
Other Study ID Numbers: 156-09-284
2010-019025-33 ( EudraCT Number )
Study First Received: April 15, 2011
Results First Received: March 28, 2017
Last Updated: May 30, 2017