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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01284114
Recruitment Status : Completed
First Posted : January 26, 2011
Results First Posted : October 22, 2012
Last Update Posted : October 22, 2012
Information provided by (Responsible Party):
Yoshiyuki Morishita, Jichi Medical University

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.

Condition or disease Intervention/treatment Phase
Hypertension Chronic Kidney Disease Drug: Aliskiren Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients
Study Start Date : February 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Aliskiren
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Aliskiren Drug: Aliskiren
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
Other Name: Direct renin inhibitor

Primary Outcome Measures :
  1. The Change of Blood Pressure [ Time Frame: baseline and 6 month ]
    The change of systolic blood pressure and diastolic blood pressure

  2. The Change of Heart Function Confirmed by Echocardiograph [ Time Frame: 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.

  3. The Change of BNP [ Time Frame: baseline and 6month ]
    Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.

  4. The Change of eGFR [ Time Frame: 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).

  5. The Change of Urine Albumin/ Creatinine Ratio (UACR). [ Time Frame: baseline and 6 months ]
    The UACR was measured at baseline, Week12 and Week24

Secondary Outcome Measures :
  1. The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM [ Time Frame: 6 months ]

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01284114

Niimi city Yukawa National health insurance clinic
Niimi, Okayama, Japan, 719-2643
Konan Hospital
Oyama, Tochigi, Japan, 329-0214
Kurosu Hospital
Sakura, Tochigi, Japan, 329-1395
Jichi Medical University
Shimotsuke, Tochigi, Japan, 3290498
Sponsors and Collaborators
Jichi Medical University
Principal Investigator: Yoshiyuki Morishita, MD, PhD Division of Nephrology, Department of Medicine, Jichi Medical University

Responsible Party: Yoshiyuki Morishita, MD. PhD, Jichi Medical University Identifier: NCT01284114     History of Changes
Other Study ID Numbers: JMU-N1
First Posted: January 26, 2011    Key Record Dates
Results First Posted: October 22, 2012
Last Update Posted: October 22, 2012
Last Verified: July 2012

Keywords provided by Yoshiyuki Morishita, Jichi Medical University:
Elderly chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency