Sympathetic Nerve Activity in Renal Failure | NCT00892892

Studies
Sympathetic Nerve Activity in Renal Failure

NCT00892892

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Withdrawn

Last Update Posted

Mar 17, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Chronic Kidney Disease
Hypertension

Interventions

Rilmenidine
Nitrendipine

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

May 1, 2009

First Submission Date that Met QC Criteria

May 1, 2009

First Posted Date

May 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2015

Last Update Posted Date

Mar 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Rilmenidine as a sympatholytic agent for three months	Drug: Rilmenidine
Arm 2	Active Comparator	Nitrendipine as a non-sympatholytic agent for three months	Drug: Nitrendipine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rilmenidine	Drug	1 mg Rilmenidine per day versus	Arm 1	Hyperium

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roland E Schmieder, MD	University of Erlangen-Nurnberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Erlangen-Nuremberg, CRC, med. Clinic 4		Erlangen	Bavaria	91054	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D006973	Hypertension

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077769	Rilmenidine
D009568	Nitrendipine

Ancestor Terms

ID	Term
D010080	Oxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided