NCT00719316

Brief Summary

The central hypothesis of this project is that Aliskiren causes a substantial decrease in MSNA in hypertensive patients with CKD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

July 1, 2008

Enrollment Period

1 year

First QC Date

July 17, 2008

Last Update Submit

January 13, 2010

Conditions

Chronic Kidney DiseaseHypertensionMuscle Sympathetic Nerve Activity

Keywords

Renin inhibitorPatientsACE inhibitor or ARBChronic Kidney DiseaseHypertension

Outcome Measures

Primary Outcomes (1)

  • Normalisation of muscle sympathetic nerve activity

    1 year

Secondary Outcomes (1)

  • Blood pressure and Blood tests

    1 year

Study Arms (2)

Group 1

EXPERIMENTAL

Patients receive Aliskiren 300mg for 6 weeks

Drug: Aliskiren

Group 2

NO INTERVENTION

4 weeks no antihypertensive medication

Interventions

AliskirenDRUG

Aliskiren 300mg per day for 6 weeks

Also known as: Rasilez 300mg per day
Group 1

Eligibility Criteria

Age25 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with stable chronic kidney disease and hypertension: i.e. using antihypertensive drugs and/or blood pressure \> 145/90 mmHg when off medication.
  • Patients on ACE inhibitor or ARB

You may not qualify if:

  • Patients with diabetes mellitus
  • Patients on renal replacement therapy
  • Pregnant patients Using of antihypertensive which cannot be stopped
  • Patients on immunosuppressive therapy and active nephrotic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center utrecht

Utrecht, Utrecht, 3584CX, Netherlands

RECRUITING

Related Publications (1)

  • Siddiqi L, Oey PL, Blankestijn PJ. Aliskiren reduces sympathetic nerve activity and blood pressure in chronic kidney disease patients. Nephrol Dial Transplant. 2011 Sep;26(9):2930-4. doi: 10.1093/ndt/gfq857. Epub 2011 Apr 5.

    PMID: 21467128DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Study Officials

  • P. J. Blankestijn, MD, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laima Siddiqi, MD

CONTACT

+ 31 88 755 7329l.siddiqi@umcutrecht.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2009

Study Completion

January 1, 2010

Last Updated

January 14, 2010

Record last verified: 2008-07

Locations

NL(1)