Sunitinib 50 mg by mouth daily for 28 consecutive days. Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

50 mg by mouth daily for 28 consecutive days

Sunitinib

Nephrectomy will occur approximately 24 hours after the last dose of sunitinib.

Nephrectomy

Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)

Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control

Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Renal Angiogram

Kentaro Ishinabe

Renal angiogram and Renal Denervation procedure

Netrod™ renal denervation (RDN) system, which is indicated for the treatment of uncontrolled hypertension. It consists of the following two components:

* Netrod™ Six-Electrode Basket Radiofrequency Renal Denervation Catheter and
* Netrod™ Renal Denervation Radiofrequency Generator The catheter's electrodes deploy into a self-adaptive basket structure, optimizing contact with the vessel wall for effective ablation.

Netrod™ six-electrode radiofrequency renal denervation system

Renal angiogram followed by Sham procedure

Patients will be remained on the catheterization table for at least 20 min prior to sheath removal.

Sham Procedure

The patient will not undergo either the renal angiogram or the RDN procedure.

Arrhythmia burden pre-to-post renal denervation as assessed by an implantable cardiac monitor

Renal Denervation

Insel Gruppe AG, University Hospital Bern

Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Renal Autologous Cell Therapy (REACT)

Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.

Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device

ultrasound renal denervation

Shenzhen Pulsecare Medical Technology Co., Ltd.

Jingfeng Wang J Wang

We attempt to identify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch

We attempt to idendtify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch.

Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation

University of Erlangen-Nürnberg Medical School

Affected patients:

Suffering from nephronophthisis or renal associated ciliopathies with known genetic diagnosis or not, Having obtained the signature of the informed consent form of patient, parent

Intervention : blood and urine sample collection Collection of urines from patients will be followed by multiomics analyses including proteome and miRNAome profiling on EVs purified from urines by ultracentrifugation and metabolomics on unfractionated urine. Biomarkers identification for ciliopathy-induced chronic kidney disease will allow to monitor the drug response in treated urine-derived renal epithelial cells.

Description: Research of therapeutic targets in the frame of nephronophthisis and renal associated ciliopathie

Healthy relatives:

Being the healthy relative (father / mother / brother / sister) of an included patient Having signed the informed consent form (patient or parent in case of minor subject) No age limit is requested for these subjects, who can be recruited from birth.

Intervention : blood and urine sample collection Collection of urines from patients will be followed by multiomics analyses including proteome and miRNAome profiling on EVs purified from urines by ultracentrifugation and metabolomics on unfractionated urine. Biomarkers identification for ciliopathy-induced chronic kidney disease will allow to monitor the drug response in treated urine-derived renal epithelial cells

Being unscathed of any chronic renal disease, with or without ciliopathies Having obtained the signature of the informed consent form No age limit is requested for these patients, who can be recruited from birth.

Intervention : blood and urine sample collection Collection of urines from patients will be followed by multiomics analyses including proteome and miRNAome profiling on EVs purified from urines by ultracentrifugation and metabolomics on unfractionated urine. Biomarkers identification for ciliopathy-induced chronic kidney disease will allow to monitor the drug response in treated urine-derived renal epithelial cells

Suffering from Chronic Kidney Disease unrelated to ciliary dysfunction (such as glomerulopathy, tubulopathy…) Having obtained the signature of the informed consent form No age limit is requested for these patients, who can be recruited from birth.

Intervention : blood and urine sample collection Collection of urines from patients will be followed by multiomics analyses including proteome and miRNAome profiling on EVs purified from urines by ultracentrifugation and metabolomics on unfractionated urine. Biomarkers identification for ciliopathy-induced chronic kidney disease will allow to monitor the drug response in treated urine-derived renal epithelial cells

Sophie AF SAUNIER

Sunitinib alone

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 1.

Nephrology practices implement a bundle in which they will encourage their patients to a) participate in a kidney disease education program providing a balanced presentation of all options including ATPs, b) use evidence-based patient decision aids that include ATPs, and c) engage in shared decision-making with staff who have been trained in communication skills and best practices.

Educate and Engage

Patients accrued and making treatment decisions while the clinic treating them is implementing Approach 2.

In addition to bundle described under "Educate and Engage," nephrology practices offer a systematic program integrating primary palliative care to support patients and their families who choose any ATP. The program closely follows patients and their families on ATP with care coordination, symptom management, advance care planning, and psychosocial support to supplement usual care from their nephrologist.

Educate and Engage Plus Kidney Supportive Care Program

Catheter-based endovascular denervation (CDN) of renal arteries only, without splanchnic nerve denervation

Renal Denervation Only

Catheter-based endovascular denervation (CDN) of renal arteries and splanchnic nerves (celiac + SMA) using radiofrequency ablation

Splanchnic Nerve Denervation

Chris Wang, MS

Suzanne Bowers, RN, BSN

Jose Wiley, MD, MPH, FACC, FACP, FSCAI

Renal nerve stimulation will be performed prior to and post renal denervation.

Renal nerve stimulation

Eileen Coen

Faisal Sharif, MD

Participants will receive patient-centered health coaching delivered by two full-time kidney health coaches for six months.

The intervention entails support from a KHC that includes:

* An initial rapport-building call
* Ongoing telephone support at least twice a month for six months
* Meeting the patient at all in-person clinic appointments
* Documenting interactions in the EMR using a customized platform

Telephone support begins with a social determinants of health (SDoH) screening tool to identify barriers and facilitators to CKD self-management and appointment adherence. This tool provides access to local resources based on the patient's ZIP code. Subsequent calls will follow up on resource usage, review CKD educational materials and treatment options, complete the Decision Aid for Renal Therapy tool, and facilitate communication through the patient portal. Each call will start with specific goals (e.g., review National Kidney Foundation CKD materials) and conclude with goals for the next session.

Kidney Health Coaching

Participants will receive the usual care based on where patients are identified (Emergency Room- ER, Primary Care, Hospital Discharge, Primary Care, or Nephrology)

ER Discharge (d/c): Participants may receive consultations and support from Care Management in the ER, such as transportation or medication assistance. Follow-up by a social worker varies post-discharge.

Hospital d/c: All hospitalized patients are assessed by the care management team to identify psychosocial needs and begin discharge planning, which may include follow-up appointments and resources. High-risk patients receive additional follow-up from a care transitions coordinator for 30 days post-discharge.

Primary Care: Patients in primary care clinics have access to various support services. Those recently hospitalized or identified as high-risk receive care coordination from social workers. Internal referrals are managed by referral coordinators, while external referrals come from clinic staff. Discharge information is provided after visits.

Nephrology: There are no coordinated support services for chronic kidney disease (CKD) patients receiving nephrology care.

Usual Care

This group does not specifically encourage or interfere with physicians' original methods of inquiry or patients providing bodily examination data.

This group encourages physicians to actively inquire or patients to voluntarily provide physical examination data during consultations.

In the intervention group, the investigators improve the process of measuring blood pressure, height, and weight, requiring timely recording of these measurements. The intervention includes:

i. Enlisting the assistance of nurses and volunteers to improve the accessibility of measurement environments and provide guidance on instrument operation.

ii. Using paper reminders at check-in stations to prompt patients to complete blood pressure and weight recordings before entering examination rooms; providing paper for recording if patients forget their health insurance cards.

iii. Providing alcohol and hand wipes outside examination rooms for disinfecting measurement instruments.

iv. Promoting the recording mode outside the check-in station.

v. Ensuring that physicians or nurses in examination rooms accurately record measurements in the medical order system.

vi. Encouraging patients to ask physicians during consultations, "Is my blood pressure and weight okay?"

Height, Weight, and Blood Pressure Measurement Procedures Improvement

All procedures will be carried out by highly experienced interventional cardiologists, each having performed a minimum of 20 RDN prior to treating study patients. All interventions will be performed with the CE-marked Symplicity SpyralTM (Medtronic, Minneapolis, MN, USA) renal denervation system following current treatment standards. Procedures will be performed as stated in the IFU. The specific ablation points will be determined by the discretion of the interventionalist.

Renal sympathetic denervation

Heart Center Leipzig - University Hospital

Philipp Lurz, Prof. Dr. med.

Karl Fengler, Dr. med.

Following angiogram, subjects found anatomically eligible and randomized to the renal denervation arm will be treated with the TIVUS™ Renal Denervation System.

Renal artery catheterization procedure used to denervate the renal sympathetic nerves in the perivascular space using ultrasound energy.

TIVUS™ Renal Denervation System

For those subjects randomized to the sham control, the angiogram will serve as the sham procedure.

Sham

Antoine Cremer, MD

Michel Azizi, MD, PhD

Roland Schmieder, MD, PhD

Horst Sievert, MD

Elias Noory, MD

Jury Schewel, MD

Christian Ukena, MD, PhD

Karl Fengler, MD

Joachim Weil, MD

K Tsioufis, MD, PhD

Maria Marketou, MD, PhD

Michalis Doumas, MD

Luigi Salemme, MD

Emanuele Barbato, MD, PhD

Susan DeRamus

Farrell O Mendelsohn

Taral Patel, MD

Maximilliano Arroyo, MD

Sasha Potter

Andre Paixao, MD

Leybi Ramirez-Kelly, PhD

Florian Radar, M.D.

Maria Thottam

David Lee, MD

Fadi Mater, MD

John Flack, MD

Craig Walker

James Jenkins, MD

Wayne Latack, MD

Michael Bloch, MD

Kintur Sanghvi, MD

Ajay Kirtane, MD

Suzanne Edwards, PhD

James Pierre-Louis

James Zidar

Deborah Cohen, MD

Farhan Ali, M.D.

Arnav Kumar, M.D.

Vamsee Yaganti, M.D.

Nayef Abouzaki, MD

renal denervation

Agnes Bosch, MD

Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, 12, 24, and 36 months.

Assigned Interventions: Device: Six-channel RF Renal Denervation System; Drug: Standardized Antihypertensive Therapy

DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)

Six-channel RF Renal Denervation System

Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1, 3, 6, and 12 months. After completing the 12-month visit, participants may transition to active RDN and then be followed up to 36 months; those declining crossover will continue follow-up at 24 and 36 months.

Assigned Interventions: Procedure: Sham operation; Drug: Standardized Antihypertensive Therapy

Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.

Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

This arm will receive the intervention in addition to usual care.

CommunityRx-Chronic Kidney Disease (CRx-CKD) is an evidence-based, low-intensity, health information technology-driven intervention designed to support chronic kidney disease management in rural eastern North Carolina. CRx-CKD integrates medical (e.g., blood pressure and glucose monitoring, eye and foot care), social (food, housing, transportation), and self-care (weight and stress management, exercise) resources. CRx-CKD comprises three components: brief education on integrated chronic kidney disease needs, a chronic kidney disease care plan that includes integrated care referrals, and clinic navigator-led, longitudinal support (12 months) for chronic kidney disease patients.

CommunityRx-Chronic Kidney Disease

This arm will not receive the intervention.

University of North Carolina, Chapel Hill

Donna K Sanderson, RN, BSN, CLHP

KidneyTIME-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Human guide support offered over a 6 month period to encourage use of the intervention and donor outreach.

Receives (1) donor search materials, (2) electronic resource access messages, (3) practical assistance to use the intervention and empower taking the outreach action and (4) telephonic human guide

Digital education outreach intervention for kidney transplant access and human guide

KidneyTime-2 is a multicomponent mobile education-outreach intervention to increase patient- and network-to-donor self-learning and outreach, about living donor kidney transplantation. Routine clinical support from non-study sources through usual Transplant Center protocols including clinic provider communications.

Receives (1) donor search materials, (2) electronic resource access messages, and (3) practical assistance to use the intervention and empower taking the outreach action.

수니티닙, 신장절제술

Paradise™ (PRDS-001) 신장 신경차단 초음파 시스템, 신장 혈관조영술

Netrod™ 6전극 고주파 신장 신경차단 시스템, 가짜 시술

신장 신경 차단술

신장 자가세포 치료(REACT)

초음파 신장 신경차단술

신장 변성술 후 환자의 혈압 예측 인자를 식별하기 위한 유전 기반 분석

설명: 신증 및 신장 관련 섬모병의 치료 목표 연구

신장절제술, 수니티닙 단독

교육 및 참여, 교육 및 참여 플러스 신장 지원 치료 프로그램

장내 신경 탈신경술, 신장 탈신경술만

신장 신경 자극

신장 건강 코칭, 일반적인 관리

신장, 체중 및 혈압 측정 절차 개선

신장 교감신경 차단술

TIVUS™ 신장신경차단 시스템, Sham

신장 변성

6채널 RF 신장 신경차단 시스템, 가짜 수술과 병행 제어(상표 및/또는 일반 명칭 없음, 빈 컨트롤 가짜 수술)

CommunityRx-만성 신장 질환

신장 이식 접근성을 위한 디지털 교육 홍보 개입 및 인간 가이드, 신장 이식 접근성만을 위한 디지털 교육 홍보 개입(무가이드)