Chronic Kidney DiseasePhase 4SNS in CRFNCT00892892
Sympathetic Nerve Activity in Renal Failure
A Phase 4 study testing Rilmenidine and Nitrendipine in people with Chronic Kidney Disease and Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Disease, Hypertension
- What is being tested?
- Rilmenidine and Nitrendipine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2009to Jun 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic renal failure stages I-IV
Who cannot join
- pregnancy and lactation
- severe heart failure or ischemic heart disease
- patients with NYHA III-IV
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Erlangen-Nuremberg, CRC, med. Clinic 4
Erlangen, Bavaria, 91054
About this study
Official title: Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure
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.
- Conditions
- Chronic Kidney Disease, Hypertension
- Being tested
- Rilmenidine, Nitrendipine
- Keywords
- sympatholytic treatment, sympathetic nerve activity
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilmenidineDrug
Also called Hyperium
1 mg Rilmenidine per day versus
NitrendipineDrug
Also called Bayotensin
20 mg Nitrendipine per day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Rilmenidine as a sympatholytic agent for three months Receives: Drug: Rilmenidine |
| Arm 2 | Active comparator | Nitrendipine as a non-sympatholytic agent for three months Receives: Drug: Nitrendipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sympathetic activation for the development and progression of chronic renal failure
Measured: 3 months
Secondary outcomes (1)
effects of a sympatholytic agent on cardiovascular reactivity to various stressors
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland E Schmieder, MD, Principal investigator, University of Erlangen-Nurnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892892
- Sponsor's protocol ID
- Re-No. 3186
- Acronym
- SNS in CRF
- Status last verified
- Mar 2015
- First submitted
- 1 May 2009
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Sympathetic Nerve System for the Pathogenesis and Progression of Chronic Kidney Failure
- ClinicalTrials.gov ID
- NCT00892892
- Acronym / sponsor ID
- SNS in CRF / Re-No. 3186
- Conditions
- Chronic Kidney Disease, Hypertension
- Keywords
- sympatholytic treatment, sympathetic nerve activity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 5 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: RilmenidineRilmenidine as a sympatholytic agent for three months |
| Arm 2 | Active comparator | Drug: NitrendipineNitrendipine as a non-sympatholytic agent for three months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- chronic renal failure stages I-IV
Key exclusion criteria (3 listed)
- pregnancy and lactation
- severe heart failure or ischemic heart disease
- patients with NYHA III-IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RilmenidineAlso: Hyperium1 mg Rilmenidine per day versus | Drug | Arm 1 |
| NitrendipineAlso: Bayotensin20 mg Nitrendipine per day | Drug | Arm 2 |
Primary outcome
sympathetic activation for the development and progression of chronic renal failure
Time frame: 3 months
1 secondary outcome
effects of a sympatholytic agent on cardiovascular reactivity to various stressors
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roland E Schmieder, MD principal investigator
University of Erlangen-Nurnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rilmenidine and Nitrendipine in people with Chronic Kidney Disease and Hypertension, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sympathetic activation for the development and progression of chronic renal failure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.