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Sympathetic Nerve Activity in Renal Failure (SNS in CRF)

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ClinicalTrials.gov Identifier: NCT00892892
Recruitment Status : Withdrawn
First Posted : May 5, 2009
Last Update Posted : March 17, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Hypertension Drug: Rilmenidine Drug: Nitrendipine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure
Study Start Date : November 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Arm 1
Rilmenidine as a sympatholytic agent for three months
Drug: Rilmenidine
1 mg Rilmenidine per day versus
Other Name: Hyperium
Active Comparator: Arm 2
Nitrendipine as a non-sympatholytic agent for three months
Drug: Nitrendipine
20 mg Nitrendipine per day
Other Name: Bayotensin


Outcome Measures

Primary Outcome Measures :
  1. sympathetic activation for the development and progression of chronic renal failure [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. effects of a sympatholytic agent on cardiovascular reactivity to various stressors [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892892


Locations
Germany
University of Erlangen-Nuremberg, CRC, med. Clinic 4
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Roland E Schmieder, MD University of Erlangen-Nurnberg
More Information

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00892892     History of Changes
Other Study ID Numbers: Re-No. 3186
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by University of Erlangen-Nürnberg Medical School:
sympatholytic treatment
sympathetic nerve activity

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Rilmenidine
Nitrendipine
Sympatholytics
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents