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| Sponsored by: |
University of Erlangen-Nürnberg |
|---|---|
| Information provided by: | University of Erlangen-Nürnberg |
| ClinicalTrials.gov Identifier: | NCT00892892 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study |
| Official Title: | Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure |
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: Experimental
Rilmenidine as a sympatholytic agent for three months
|
Drug: Rilmenidine
1 mg Rilmenidine per day versus
|
|
Arm 2: Active Comparator
Nitrendipine as a non-sympatholytic agent for three months
|
Drug: Nitrendipine
20 mg Nitrendipine per day
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Roland E Schmieder, MD | ++49(0)91318536248 | roland.schmieder@uk-erlangen.de |
| Contact: Stephanie I Titze, MD | ++49(0)91318543068 | stephanie.titze@uk-erlangen.de |
| Germany, Bavaria | |
| University of Erlangen-Nuremberg, CRC, med. Clinic 4 | Recruiting |
| Erlangen, Bavaria, Germany, 91054 | |
| Contact: Roland E Schmieder, MD ++49(0)91318543068 stephanie.titze@uk-erlangen.de | |
| Sub-Investigator: Stephanie I Titze, MD | |
| Sub-Investigator: Tilmann Ditting, MD | |
| Principal Investigator: | Roland E Schmieder, MD | University of Erlangen-Nurnberg |
More Information
| Responsible Party: | University of Erlangen-Nurnberg ( Role of the sympathetic nervous system for the pathogenesis and progression of chronic renal failure ) |
| Study ID Numbers: | Re-No. 3186 |
| Study First Received: | May 1, 2009 |
| Last Updated: | May 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00892892 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
sympatholytic treatment sympathetic nerve activity |
|
Neurotransmitter Agents Vasodilator Agents Renal Insufficiency Adrenergic alpha-Agonists Adrenergic Agents Nitrendipine Kidney Failure, Chronic Disease Progression Vascular Diseases Calcium Channel Blockers |
Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Calcium, Dietary Urologic Diseases Renal Insufficiency, Chronic Rilmenidine Kidney Diseases Kidney Failure Hypertension |
|
Neurotransmitter Agents Vasodilator Agents Renal Insufficiency Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Nitrendipine Physiological Effects of Drugs Kidney Failure, Chronic Vascular Diseases Calcium Channel Blockers Cardiovascular Agents |
Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions Membrane Transport Modulators Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Rilmenidine Cardiovascular Diseases Kidney Diseases Hypertension Kidney Failure |
