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

NCT01284114 | Completed Phase 4 Results

• 1 other identifier: JMU-N1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Hypertension; Chronic Kidney Disease

Keywords

Elderly chronic kidney disease; Hypertension; Aliskiren

Outcome Measures

Primary Outcomes (5)

• The Change of Blood Pressure

  The change of systolic blood pressure and diastolic blood pressure

  baseline and 6 month

• 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.

  baseline and 6 month

• The Change of BNP

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

  baseline and 6month

• 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).

  baseline and 6 month

• The Change of Urine Albumin/ Creatinine Ratio (UACR).

  The UACR was measured at baseline, Week12 and Week24

  baseline and 6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (1)

Aliskiren

ACTIVE COMPARATOR

Drug: Aliskiren

Interventions

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

Also known as: Direct renin inhibitor

Aliskiren

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Chronic kidney disease
• Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg)
• Elderly people(\>=65 years old)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jichi Medical University: lead

Study Sites (4)

Niimi city Yukawa National health insurance clinic

Niimi, Okayama-ken, 719-2643, Japan

Location

Konan Hospital

Oyama, Tochigi, 329-0214, Japan

Location

Kurosu Hospital

Sakura, Tochigi, 329-1395, Japan

Location

Jichi Medical University

Shimotsuke, Tochigi, 3290498, Japan

Location

Related Publications (1)

• Morishita Y, Hanawa S, Chinda J, Iimura O, Tsunematsu S, Kusano E. Effects of aliskiren on blood pressure and the predictive biomarkers for cardiovascular disease in hemodialysis-dependent chronic kidney disease patients with hypertension. Hypertens Res. 2011 Mar;34(3):308-13. doi: 10.1038/hr.2010.238. Epub 2010 Dec 2.

  PMID: 21124333 BACKGROUND

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Interventions

aliskiren; Renin Inhibitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Dr. Yoshiyuki Morishita
• Organization: Division of Nephrology, Department of Internal Medicine, Jichi Medical University

ymori@jichi.ac.jp

81-285-58-7346

Study Officials

• Yoshiyuki Morishita, MD, PhD

  Division of Nephrology, Department of Medicine, Jichi Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD

Study Record Dates

• First Submitted: January 25, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 22, 2012
• Results First Posted: October 22, 2012

Record last verified: 2012-07

Locations

JP (4)