Trial Outcomes & Findings for Effect of Short Term Aliskiren Treatment in Kidney Transplant Patients (NCT NCT01437943)
NCT ID: NCT01437943
Last Updated: 2017-05-01
Results Overview
Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
180 days (completion of treatment)
Results posted on
2017-05-01
Participant Flow
10 subjects were recruited into the trial however none completed the treatment/follow-up as Novartis terminated all studies involving Aliskiren.
Participant milestones
| Measure |
Aliskiren
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Aliskiren
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days
|
|---|---|---|
|
Overall Study
Aliskiren trials terminated by Novartis
|
4
|
2
|
|
Overall Study
Subject expressed pregnancy plans
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Effect of Short Term Aliskiren Treatment in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
Aliskiren
n=7 Participants
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
n=3 Participants
Placebo daily for 180 days
Placebo: Take 1 tablet (0 mg) daily for 180 days
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
56.6 years
n=5 Participants
|
48 years
n=7 Participants
|
54 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 days (completion of treatment)Population: Only one subject completed study drug and no subjects had completed the 6 month P-MR scan at the time the trial was terminated. Because of this, we were not able to analyze the primary outcome.
Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy
Outcome measures
| Measure |
Aliskiren
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
Placebo identical to Aliskiren drug daily for 180 days
Placebo: Take 1 tablet (0 mg) daily for 180 days.
|
|---|---|---|
|
Effect of Aliskiren on Kidney Metabolism
|
0
|
0
|
Adverse Events
Aliskiren
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aliskiren
n=7 participants at risk
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
n=3 participants at risk
Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days
|
|---|---|---|
|
Gastrointestinal disorders
GI bleed
|
14.3%
1/7 • Number of events 2 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
0.00%
0/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Blood and lymphatic system disorders
Left knee hemarthrosis and DVT
|
14.3%
1/7 • Number of events 1 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
0.00%
0/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Infections and infestations
Salmonella group B
|
0.00%
0/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
Other adverse events
| Measure |
Aliskiren
n=7 participants at risk
Aliskiren 150 mg daily for 180 days
Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days
|
Placebo
n=3 participants at risk
Placebo daily for 180 days
Placebo: Take 1 tablet by mouth daily for 180 days
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
71.4%
5/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Cardiac disorders
Hypotension
|
0.00%
0/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity weakness
|
14.3%
1/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
0.00%
0/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
|
Renal and urinary disorders
Elevated creatinine
|
0.00%
0/7 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
33.3%
1/3 • Adverse event data was collected continuously during subject participation starting at consent through month 6 or termination of the trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place