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Completed

NCT Number: NCT01284114

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Niimi city Yukawa National health insurance clinic, Niimi, Okayama-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aliskiren

Drug

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 names: Direct renin inhibitor

Primary outcomes

  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 outcomes

  1. The Change of Oxidative Stress Markers Confirmed by Plasma Level of 8-OHdG and d-ROM

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Jichi Medical University

Other

Registry information

Official study title

Effects of Aliskiren on Blood Pressure, Heart and Kidney in Elderly Hypertensive Chronic Kidney Disease Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 26, 2011
Registry last updated
Oct 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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