Chronic Kidney Disease, Hypertension
Conditions
Keywords
Elderly chronic kidney disease, Hypertension, Aliskiren
Brief summary
The purpose of this study is to determine whether aliskiren is effective in the treatment of blood pressure, hear function, renal function in elderly hypertensive chronic kidney disease (CKD) patients.
Detailed description
Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called Cardio-renal Continuum. The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions. The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS, leading to a reactive rise in plasma renin activity (PRA). Aliskiren, an oral direct renin inhibitor, is effective against essential hypertension by reducing PRA, resulting in more complete suppression of RAS; however, little is known about the effects of aliskiren on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of aliskiren on heart and kidney functions in elderly hypertensive CKD patients.
Interventions
DRUGAliskiren
150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
Sponsors
Jichi Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Chronic kidney disease * Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg) * Elderly people(\>=65 years old)
Exclusion criteria
* The patients who are already taking aliskiren * The patients who are receiving hemodialysis or peritoneal dialysis * The patients who are taking cyclosporin * The patients who have hyperkalemia(\>=5.5mEq/ml) * Severe heart failure (\>=NYHA class III) * Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (\>=HbA1c 9.0&) * Severe liver dysfunction (five folds increased AST or ALT than standard values)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change of Blood Pressure | baseline and 6 month | The change of systolic blood pressure and diastolic blood pressure |
| The Change of Heart Function Confirmed by Echocardiograph | baseline and 6 month | 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. |
| The Change of BNP | baseline and 6month | Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month. |
| The Change of eGFR | baseline and 6 month | 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). |
| The Change of Urine Albumin/ Creatinine Ratio (UACR). | baseline and 6 months | The UACR was measured at baseline, Week12 and Week24 |
Secondary
| Measure | Time frame |
|---|---|
| The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM | 6 months |
Countries
Japan
Participant flow
Recruitment details
Patients were recruited between February 2011 and December 2011 in Tochigi prefecture and Okayama prefecture in Japan
Pre-assignment details
4 week observation period to fix any drugs, including existing antihypertensives
Participants by arm
| Arm | Count |
|---|---|
| Aliskiren | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | dizziness | 1 |
| Overall Study | From the results of ALLTITUDE study | 1 |
| Overall Study | Symptomatic hypotension | 1 |
| Overall Study | viral infection | 1 |
Baseline characteristics
| Characteristic | Aliskiren |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 75.2 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment Japan | 23 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
The Change of Blood Pressure
The change of systolic blood pressure and diastolic blood pressure
Time frame: baseline and 6 month
Population: We analyzed all patients who completed study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aliskiren | The Change of Blood Pressure | systolic blood pressure | -22.7 mmHg | Standard Deviation 0.7 |
| Aliskiren | The Change of Blood Pressure | diastolic blood pressure | -5 mmHg | Standard Deviation -0.5 |
Primary
The Change of BNP
Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.
Time frame: baseline and 6month
Population: We analyzed all patients who completed study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | The Change of BNP | 6.7 pg/ml | Standard Deviation -4.9 |
Primary
The Change of eGFR
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).
Time frame: baseline and 6 month
Population: We analyzed all patients who completed study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | The Change of eGFR | -0.9 mL/min/1.73m2 | Standard Deviation -0.1 |
Primary
The Change of Heart Function Confirmed by Echocardiograph
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.
Time frame: baseline and 6 month
Population: We analyzed participants who copmleted this study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | The Change of Heart Function Confirmed by Echocardiograph | -0.3 % of stroke vulume/enddiastolic volume | Standard Deviation -1.1 |
Primary
The Change of Urine Albumin/ Creatinine Ratio (UACR).
The UACR was measured at baseline, Week12 and Week24
Time frame: baseline and 6 months
Population: We analyzed all patients who completed this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aliskiren | The Change of Urine Albumin/ Creatinine Ratio (UACR). | -337.5 mg/g | Standard Deviation -484.6 |
Secondary
The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM
Time frame: 6 months