Trial Outcomes & Findings for Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients (NCT NCT01284114)

Results Overview

The change of systolic blood pressure and diastolic blood pressure

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

baseline and 6 month

Results posted on

2012-10-22

Participant Flow

Patients were recruited between February 2011 and December 2011 in Tochigi prefecture and Okayama prefecture in Japan

4 week observation period to fix any drugs, including existing antihypertensives

Participant milestones

Participant milestones
Measure	Aliskiren Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
Overall Study STARTED	23
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Aliskiren Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
Overall Study viral infection	1
Overall Study From the results of ALLTITUDE study	1
Overall Study Symptomatic hypotension	1
Overall Study dizziness	1

Baseline Characteristics

Effects of Aliskiren in Elderly Hypertensive Chronic Kidney Disease (CKD) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aliskiren n=23 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	23 Participants n=93 Participants
Age Continuous	75.2 years STANDARD_DEVIATION 7.2 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	11 Participants n=93 Participants
Region of Enrollment Japan	23 participants n=93 Participants

PRIMARY outcome

Timeframe: baseline and 6 month

Population: We analyzed all patients who completed study.

The change of systolic blood pressure and diastolic blood pressure

Outcome measures

Outcome measures
Measure	Aliskiren n=19 Participants
The Change of Blood Pressure systolic blood pressure	-22.7 mmHg Standard Deviation 0.7
The Change of Blood Pressure diastolic blood pressure	-5 mmHg Standard Deviation -0.5

PRIMARY outcome

Timeframe: baseline and 6 month

Population: We analyzed participants who copmleted this study

Left ventricular ejection fraction (LVEF)were measured by echocardiogram at baseline and 6 month. Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.

Outcome measures

Outcome measures
Measure	Aliskiren n=19 Participants
The Change of Heart Function Confirmed by Echocardiograph	-0.3 % of stroke vulume/enddiastolic volume Standard Deviation -1.1

PRIMARY outcome

Timeframe: baseline and 6month

Population: We analyzed all patients who completed study.

Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.

Outcome measures

Outcome measures
Measure	Aliskiren n=19 Participants
The Change of BNP	6.7 pg/ml Standard Deviation -4.9

PRIMARY outcome

Timeframe: baseline and 6 month

Population: We analyzed all patients who completed study.

eGFR was calculated at baseline and at 6 month using a modified version of the Modification of Diet in Renal Disease (MDRD) formula of the Japanese Society of Nephrology as follows: eGFR (ml/min/1.73 m2) = 194 × age-0.287 × serum creatinine-1.094 (multiplied by 0.739 for females).

Outcome measures

Outcome measures
Measure	Aliskiren n=19 Participants
The Change of eGFR	-0.9 mL/min/1.73m2 Standard Deviation -0.1

PRIMARY outcome

Timeframe: baseline and 6 months

Population: We analyzed all patients who completed this study.

The UACR was measured at baseline, Week12 and Week24

Outcome measures

Outcome measures
Measure	Aliskiren n=19 Participants
The Change of Urine Albumin/ Creatinine Ratio (UACR).	-337.5 mg/g Standard Deviation -484.6

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome data not reported

Adverse Events

Aliskiren

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yoshiyuki Morishita

Division of Nephrology, Department of Internal Medicine, Jichi Medical University

Phone: 81-285-58-7346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place