Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease

NCT02002585 | Unknown Phase 2

• 1 other identifier: KPS1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney protection study (KPS 1) is a prospective randomized clinical study comparing the use of renal denervation (RDN) and optimal medical therapy in subjects with chronic kidney disease stage 3-4 and resistant arterial hypertension to optimal medical therapy alone. Renal denervation is a modern endovascular method used to treat resistant hypertension. The method is being extended to other groups of patients, where the sympathetic tone is increased beyond resistant hypertension. Because of the character of the disease, we hypothesize that renal denervation can reduce or prevent progressive deterioration of kidney functions in this patient population. The aim of this clinical study is to show that renal denervation has protective effects on the progression of chronic renal insufficiency.

Conditions

Arterial Hypertension; Chronic Renal Insufficiency

Keywords

Renal protection; Renal sympathetic denervation

Outcome Measures

Primary Outcomes (5)

• The changes of eGFR by MDRD

  The changes of the value of eGFR measured using the MDRD equation in both groups measure at baseline and after 6 months

  6 months

• Changes in proteinuria (Microalbuminuria) in 6 months

  the change in the value of proteinuria expressed in g/24hrs or microalbuminuria expressed in ug/24hrs measured at baseline compared to value at 6 month in both study groups

  6 months

• Changes in the value of Cystatin C

  Changes in the value of Cystatin C measure at baseline and after 6 months in both groups

  6 months

• Time to the development of end-stage renal disease (ESRD)/Hemodialysis

  The time to the development of end-stage renal disease (ESRD)/Hemodialysis in both groups

  3 years

• combined renal endpoint

  the combination of all primary outcomes measured compared to baseline in both groups

  6 months

Secondary Outcomes (8)

• Total mortality

  3 years

• The total cardiovascular mortality

  3 years

• total renal mortality

  3 years

• changes in blood pressure

  3 years

• •Changes in concentration of Blood urea Nitrogen (BUN) , creatinine in 6 months, 3 years

  3 years

Study Arms (2)

RDN and optimal medical therapy

EXPERIMENTAL

Renal denervation will be performed using the available denervation device with a european approval according to current guidelines. The same device will be used for all patients in this arm to avoid efficacy bias.

Procedure: Renal denervation

optimal medical therapy alone

NO INTERVENTION

Group of patients who will be treated only with optimal medical therapy and will not be denervated. Subsequently, the patients will be followed in our cardiology and nephrology department according to the study flowchart for 3 years according to the standard of care in our institution for patients with chronic renal insufficiency.

Interventions

Renal denervation PROCEDURE

Catheter based renal sympathetic denervation is a endovascular method used for the treatment of resistent hypertension.

Also known as: RDN - Renal sympathetic denervation

RDN and optimal medical therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age between 18-80 years
• Chronic renal insufficiency in CKD 3-4 from nephrologist (eGFR (MDRD) ≤ 45 ml/min/1.73 m2)
• Arterial hypertension treated with:
• systolic BP ≥ 140 mmHg + at least 3 antihypertensive drugs Including a diuretic systolic BP ≥ 135 mmHg + 3 antihypertensives Including a diuretics + diabetes mellitus type 2.
• systolic BP ≥ 130 mmHg on 24 hr ABPM + 3 antihypertensive drugs Including a diuretics
• Renal artery diameter ≥ 4 mm according to the renal angiography (documented on quantitative renal angiography), renal artery length at least 20mm

You may not qualify if:

• Secondary hypertension
• White coat hypertension
• abnormalities in renal angiogram disqualifying for RDN
• Life expectancy \< 1 year
• Type 1. Diabetes mellitus
• Significant stenotic valvular heart disease
• Acute coronary syndrome of unstable angina in the past 6 months

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator
• Na Homolce Hospital: collaborator
• Mount Sinai Hospital, New York: collaborator

Study Sites (1)

Charles University in Prague

Prague, 12808, Czechia

RECRUITING

MeSH Terms

Conditions

Hypertension; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Claude Lubanda, Ass.Prof. MD

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Claude Lubanda, Ass.Prof. MD

CONTACT

+420224962692; Jean-Claude.Lubanda@vfn.cz

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 6, 2013

Record last verified: 2013-12

Locations

CZ (1)