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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yoshiyuki Morishita, Jichi Medical University
ClinicalTrials.gov Identifier:
NCT01284114
First received: January 25, 2011
Last updated: September 19, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Hypertension
Chronic Kidney Disease
Drug: Aliskiren
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients

Resource links provided by NLM:


Further study details as provided by Jichi Medical University:

Primary Outcome Measures:
  • The Change of Blood Pressure [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]
    The change of systolic blood pressure and diastolic blood pressure

  • The Change of Heart Function Confirmed by Echocardiograph [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline and 6month ] [ Designated as safety issue: Yes ]
    Plasma BNP level were measured by the radioimmunoassay (RIA) method at baseline and 6month.

  • The Change of eGFR [ Time Frame: baseline and 6 month ] [ Designated as safety issue: Yes ]
    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). [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
    The UACR was measured at baseline, Week12 and Week24


Secondary Outcome Measures:
  • The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: February 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284114

Locations
Japan
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
Investigators
Principal Investigator: Yoshiyuki Morishita, MD, PhD Division of Nephrology, Department of Medicine, Jichi Medical University
  More Information

Publications:
Responsible Party: Yoshiyuki Morishita, MD. PhD, Jichi Medical University
ClinicalTrials.gov Identifier: NCT01284114     History of Changes
Other Study ID Numbers: JMU-N1
Study First Received: January 25, 2011
Results First Received: July 5, 2012
Last Updated: September 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Jichi Medical University:
Elderly chronic kidney disease
Hypertension
Aliskiren

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

ClinicalTrials.gov processed this record on November 27, 2014