BridgeMD
New treatment option for Chronic Kidney Diseases
Official title Nephrospec Switzerland
ClinicalTrials.gov ID: NCT06194591
What this study is testing
- What it's testing
- This is a randomized, double-blind sham-controlled monocentric trial. 30 patients that are diagnosed with hypertension and with moderate to severe chronic kidney disease are included in this trial.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 82
You may be able to join if
- Age: 18 years to 82 years.
- Patient is diagnosed with Hypertension, i.e. home,office and/or 24h systolic blood pressure ≥135 mmHg (as per ISH guidelines, 2020), currently on...
- Patients diagnosed with moderate to severe chronic renal failure (eGFR 20-70 mL/min/1.73m2) who are currently on stable medical therapy as prescribed...
- Patients with eGFR between 60-90 ml/min/1.73m2 and albuminuria \>=30mg/mmol in spot urine or \>=300mg/day in 24h urine collection
- Patient is able and willing to comply with the required follow-up schedule.
You likely can't join if
- Hypertension: Individual's systolic BP is over 180mmHg when receiving stable medical medication regimen as prescribed by a physician, of none, one...
- History of previous renal artery stent. Stent or other intervention involving renal arteries including but not limited to renal denervation...
- Kidney conditions non compatible with the study: Patient has an eGFR \<20 ml/min/1.73m², is on Dialysis or has had a kidney transplant performed...
- Symptomatic patients (Macrohematuria) with a decrease of over 2 grams in Hb.
- Hemoglobin (Hb) ≤ 9 grams per deciliter (blood).
- Coagulation issues: Bleeding tendency resulting from hematologic disease. people having INR \> 2.5 and PT, PTT and platelet count which deviates from...
See the full eligibility criteria
Who can join
- Age: 18 years to 82 years.
- Patient is diagnosed with Hypertension, i.e. home,office and/or 24h systolic blood pressure ≥135 mmHg (as per ISH guidelines, 2020), currently on stable (over 60 days) medical therapy as prescribed by a physician, of...
- Patients diagnosed with moderate to severe chronic renal failure (eGFR 20-70 mL/min/1.73m2) who are currently on stable medical therapy as prescribed by a physician.
- Patients with eGFR between 60-90 ml/min/1.73m2 and albuminuria \>=30mg/mmol in spot urine or \>=300mg/day in 24h urine collection
- Patient is able and willing to comply with the required follow-up schedule.
- Patient is capable of giving an informed consent.
What rules you out
- Hypertension: Individual's systolic BP is over 180mmHg when receiving stable medical medication regimen as prescribed by a physician, of none, one, or more antihypertensive medication classes at maximally tolerated...
- History of previous renal artery stent. Stent or other intervention involving renal arteries including but not limited to renal denervation procedures.
- Kidney conditions non compatible with the study: Patient has an eGFR \<20 ml/min/1.73m², is on Dialysis or has had a kidney transplant performed. Active pyelonephritis. History of or current kidney stones. Patients with...
- Symptomatic patients (Macrohematuria) with a decrease of over 2 grams in Hb.
- Hemoglobin (Hb) ≤ 9 grams per deciliter (blood).
- Coagulation issues: Bleeding tendency resulting from hematologic disease. people having INR \> 2.5 and PT, PTT and platelet count which deviates from the clinical laboratory normal reference range.
- Diseases non compatible with the study: Recent (less than 6 months) history of myocardial infarction, PCI, stroke or hospitalization for HFrEF (heart failure with reduced ejection fraction). Individual has type 1...
- Active Cancer - primary tumor or metastatic, such as liver, renal, testicular, abdominal tumor or local tumor at treatment area..
- Treatment non compatible with the study: Patients that have been treated with immunosuppression in the last 3 months. Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory...
- Technical impossibility to participate: Local infection of the skin at the area to be in contact with the applicator.
- Known allergy to Sonovue® contrast product (hypersensibility to sulfur hexyfluoride or another component).
- No other contraindication to SonoVue, ie. patients with right-to-left shunts, severe pulmonary hypertension (pulmonary arterial pressure \> 90 mm Hg), uncontrolled systemic hypertension and in adult patients with...
- Contraindication to undergo MR-imaging such as the presence of a pacemaker or other implanted metallic device or severe claustrophobia.
- Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject/ Unable to obtain consent
- Known or suspected non-compliance, drug or alcohol abuse
- Individual works night shifts.
- Individual is pregnant, breast feeding or planning to become pregnant.
- Individual does not want to be informed in case of accidental finding related to individual's health discovered during imaging or other study-related exams.
- Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation,
- Previous enrolment into the current investigation,
- Enrolment of the PI, his/her family members, employees, and other dependent persons
The study team makes the final eligibility decision.
Where it's taking place
- Lausanne, Canton of Vaud, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 82 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lausanne, Canton of Vaud, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.