Sympathetic Nerve Activity in Renal Failure (SNS in CRF)

March 16, 2015 updated by: University of Erlangen-Nürnberg Medical School

Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure

The primary purpose is to assess the role of sympathetic activation for the development and progression of chronic renal failure. Using microneurography sympathetic activity will be registered in various stages of kidney affection or failure and hypertension.

A sympatholytic agent will be compared with a non-sympatholytic drug to asses the effect sympathetic activation and on the progression of kidney disease.

The effects of a sympatholytic agent on cardiovascular reactivity to various stressors wil be examined.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University of Erlangen-Nuremberg, CRC, med. Clinic 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic renal failure stages I-IV

Exclusion Criteria:

  • pregnancy and lactation
  • severe heart failure or ischemic heart disease
  • patients with NYHA III-IV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
Rilmenidine as a sympatholytic agent for three months
Drug: Rilmenidine
1 mg Rilmenidine per day versus
Other Names:
  • Hyperium
ACTIVE_COMPARATOR: Arm 2
Nitrendipine as a non-sympatholytic agent for three months
Drug: Nitrendipine
20 mg Nitrendipine per day
Other Names:
  • Bayotensin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
sympathetic activation for the development and progression of chronic renal failure
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
effects of a sympatholytic agent on cardiovascular reactivity to various stressors
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

May 1, 2009

First Submitted That Met QC Criteria

May 1, 2009

First Posted (ESTIMATE)

May 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 16, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Re-No. 3186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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