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Sympathetic Nerve Activity in Renal Failure (SNS in CRF)

Primary Purpose

Chronic Kidney Disease, Hypertension

Status
Withdrawn
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Rilmenidine
Nitrendipine
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring sympatholytic treatment, sympathetic nerve activity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Rilmenidine as a sympatholytic agent for three months

Nitrendipine as a non-sympatholytic agent for three months

Outcomes

Primary Outcome Measures

sympathetic activation for the development and progression of chronic renal failure

Secondary Outcome Measures

effects of a sympatholytic agent on cardiovascular reactivity to various stressors

Full Information

First Posted
May 1, 2009
Last Updated
March 16, 2015
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00892892
Brief Title
Sympathetic Nerve Activity in Renal Failure
Acronym
SNS in CRF
Official Title
Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Hypertension
Keywords
sympatholytic treatment, sympathetic nerve activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Rilmenidine as a sympatholytic agent for three months
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Nitrendipine as a non-sympatholytic agent for three months
Intervention Type
Drug
Intervention Name(s)
Rilmenidine
Other Intervention Name(s)
Hyperium
Intervention Description
1 mg Rilmenidine per day versus
Intervention Type
Drug
Intervention Name(s)
Nitrendipine
Other Intervention Name(s)
Bayotensin
Intervention Description
20 mg Nitrendipine per day
Primary Outcome Measure Information:
Title
sympathetic activation for the development and progression of chronic renal failure
Time Frame
3 months
Secondary Outcome Measure Information:
Title
effects of a sympatholytic agent on cardiovascular reactivity to various stressors
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland E Schmieder, MD
Organizational Affiliation
University of Erlangen-Nurnberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Erlangen-Nuremberg, CRC, med. Clinic 4
City
Erlangen
State/Province
Bavaria
ZIP/Postal Code
91054
Country
Germany

12. IPD Sharing Statement

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Sympathetic Nerve Activity in Renal Failure

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