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Trial Outcomes & Findings for Tolvaptan in Hyponatremic Cancer Patients (NCT NCT01199198)

NCT ID: NCT01199198

Last Updated: 2020-09-23

Results Overview

Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

52 participants

Primary outcome timeframe

14 days

Results posted on

2020-09-23

Participant Flow

Recruitment Period: May 5, 2011 to July 13, 2012. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 52 participants enrolled, only 48 patients were randomized to participate in the study. Two participants were not randomized due to contra indicated medication and another two were not randomized due to exclusion criteria. The study was stopped for superiority.

Participant milestones

Participant milestones
Measure
Tolvaptan Group
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
Placebo orally once a day for 14 days.
Overall Study
STARTED
24
24
Overall Study
COMPLETED
17
13
Overall Study
NOT COMPLETED
7
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Tolvaptan Group
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
Placebo orally once a day for 14 days.
Overall Study
Adverse Event
3
0
Overall Study
Lost to Follow-up
1
5
Overall Study
Withdrawal by Subject
1
2
Overall Study
ICU Transfer
1
2
Overall Study
Hospice-care transfer
1
2

Baseline Characteristics

Tolvaptan in Hyponatremic Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tolvaptan Group
n=17 Participants
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
n=13 Participants
Placebo orally once a day for 14 days.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
60 years
n=5 Participants
69 years
n=7 Participants
65 years
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
7 Participants
n=7 Participants
16 Participants
n=5 Participants
Region of Enrollment
United States
17 participants
n=5 Participants
13 participants
n=7 Participants
30 participants
n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: "Evaluable participants" are defined as all participants excluding those who drop out of the study due to non-study related reasons. Participants who are lost to follow-up for unknown or study related reasons will be counted as failures based on the intent to treat principal.

Compare proportion of hyponatremia cancer patients with a normalized serum sodium concentration at day 14 between those treated with Tolvaptan and those treated with a placebo (standard of care). Proportion of participants whose serum sodium concentration is corrected to at least 136 mEq/Lon day14.

Outcome measures

Outcome measures
Measure
Tolvaptan Group
n=17 Participants
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
n=13 Participants
Placebo orally once a day for 14 days.
Participants Whose Serum Sodium Concentration Corrected to at Least 135 mEq/L on Day 14
16 participants
1 participants

SECONDARY outcome

Timeframe: From administration of treatment to time of discharge

Population: "Evaluable participants" are defined as all participants excluding those who drop out of the study due to non-study related reasons. Participants who are lost to follow-up for unknown or study related reasons will be counted as failures based on the intent to treat principal.

Outcome measures

Outcome measures
Measure
Tolvaptan Group
n=17 Participants
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
n=13 Participants
Placebo orally once a day for 14 days.
Length of Stay in Hospital
21 days
Standard Deviation 15
26 days
Standard Deviation 15

Adverse Events

Tolvaptan Group

Serious events: 17 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Tolvaptan Group
n=17 participants at risk
Starting dose 15 mg orally once a day for 14 days.
Placebo Group
n=13 participants at risk
Placebo orally once a day for 14 days.
General disorders
Pain
100.0%
17/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
Gastrointestinal disorders
Nausea
11.8%
2/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
Skin and subcutaneous tissue disorders
Edema
100.0%
17/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
Infections and infestations
Infections (any type)
76.5%
13/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
0.00%
0/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
General disorders
Hypotension
47.1%
8/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
General disorders
Worsening of Edema
17.6%
3/17 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.
0.00%
0/13 • Adverse event collection through follow up, anticipated Day 30 +/- 5 days. Overall collection period: May 10, 2011 to August 24, 2012.

Other adverse events

Adverse event data not reported

Additional Information

Carmen Escalante,MD/Chair, General Internal Med

University of Texas (UT) MD Anderson Cancer Center

Phone: (713) 745-4516

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place