NCT00892892

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

May 1, 2009

Last Update Submit

March 16, 2015

Conditions

Chronic Kidney DiseaseHypertension

Keywords

sympatholytic treatmentsympathetic nerve activity

Outcome Measures

Primary Outcomes (1)

  • sympathetic activation for the development and progression of chronic renal failure

    3 months

Secondary Outcomes (1)

  • effects of a sympatholytic agent on cardiovascular reactivity to various stressors

    3 months

Study Arms (2)

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

RilmenidineDRUG

1 mg Rilmenidine per day versus

Also known as: Hyperium
Arm 1
NitrendipineDRUG

20 mg Nitrendipine per day

Also known as: Bayotensin
Arm 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic renal failure stages I-IV

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicHypertension

Interventions

RilmenidineNitrendipine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

OxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDihydropyridinesPyridines

Study Officials

  • Roland E Schmieder, MD

    University of Erlangen-Nurnberg

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 5, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

DE(1)