Sympathetic Nerve Activity in Renal Failure (SNS in CRF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00892892
First received: May 1, 2009
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Chronic Kidney Disease
Hypertension
Drug: Rilmenidine
Drug: Nitrendipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • sympathetic activation for the development and progression of chronic renal failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • effects of a sympatholytic agent on cardiovascular reactivity to various stressors [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00892892     History of Changes
Other Study ID Numbers: Re-No. 3186
Study First Received: May 1, 2009
Last Updated: October 12, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency
Rilmenidine
Nitrendipine
Sympatholytics
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on July 24, 2014