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

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

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

Renal nerve stimulation

Eileen Coen

Faisal Sharif, MD

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

* Diagnosed acute lymphatic leukemia
* Treatment day \< 50 according to therapy protocol / no administration of CPM before first examination
* From 3 years to \< 18 years

Single Examination: ULM of the kidney after application of a contrast medium (SonoVue®, intravenous).

Ultrasound Localization Microscopy (ULM)

Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access.

Blood sample

Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes.

Urinanalysis

Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others.

Renal sonography

* Diagnosed acute lymphatic leukemia
* Completed oncological treatment
* From 3 years to \< 18 years

ULM of the kidney after application of a contrast medium (SonoVue®, intravenous) at two different time points:

Timepoint 1: Before initiation of therapy, latest day 50 before 1st high-dose methotrexate or cyclophosphamide.

Timepoint 2: After termination of intensive treatment (after 6-9 months).

Blood draw (including BB, Diff, Glucose, Na, K, Cl, Ca, LDH, Crea, Cystatin C, Uric Acid, CRP, Albumin, Ferritin, Total Protein) through venous access at Timepoint 1 and 2.

Examination of urine for erythrocytes, leukocytes, pH value, nitrite, protein, blood, and electrolytes at Timepoint 1 and Timepoint 2.

Renal sonography including resistance index (RI), Doppler signal, flow velocity, and others at time point 1 and time point 2.

Axel Karow, MD

Alexander Dierl, MD

Eva-Maria Wild, MD

Henriette Grieshaber Bouyer Mandelbaum, MD

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.

renal denervation

Agnes Bosch, MD

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

Participants in this arm will first be shown a new user interface template report for communication Chronic Kidney Disease (CKD) lab results. This version emphasizes functional interpretation of kidney health and likelihood of progression over the next two years. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

A behavioral intervention delivered through a personalized Electronic Health Record (EHR)-integrated lab result communication tool designed to improve emotional and cognitive responses to lab results among adults aged 65+. The tool applies behavioral science principles such as risk personalization, simplified messaging, and visual framing to reduce patient anxiety, enhance understanding, and support informed decision-making.

Chronic Kidney Disease (CKD) Lab Result Communication Tool

Participants in this arm will first be shown a new user interface template report for communication CKD lab results. This version emphasizes comparative normalization by presenting personalized CKD risk in relation to results commonly observed among similar adults of comparable age and clinical characteristics. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

Participants in this arm will first be shown a new user interface template report for communication CKD lab results. This version integrates both outcome expectancy and comparative normalization by presenting personalized CKD risk alongside functional interpretation of kidney health and contextual comparison of similar adults. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation. Their responses will be locked in. Immediately afterward, participants will be shown the control version and asked to re-evaluate their responses with reference to their earlier answers.

Participants in this arm will only be shown control version, the standard communication CKD lab results. They will answer a series of questions assessing understanding, emotional response, and likelihood of behavior change based on this presentation.

Program Manager

Assistant Clinical Research Coordinator

Catherine A Sarkisian, MD, MSHS

Richard K Leuchter, MD

Radical nephrectomy will be used to remove a cT1a renal mass in an altruistic kidney donor. The kidney obtained from the radical nephrectomy participant with the cT1a mass removed will be transplanted to the recipient using an allograft.

Donor participants will undergo laparoscopic radical nephrectomy (RN) . Donor kidney then will undergo cold perfusion and ex-vivo partial nephrectomy (PN) with cold ischemia. During PN, careful inspection of tumor will be performed to ensure it is well-encapsulated. If any infiltrative features (versus well encapsulated tumor) are noted intraoperatively then transplant will not be performed. Multiple surgical margins will be sent (either frozen section or standard with priority). If final margins are positive or concerning, then transplant will not be performed. Biopsies of the tumor will be performed and sent to pathology (either frozen section or standard with priority).

Donor Radical and Partial Nephrectomy

The donor kidney will remain on ice while pathologic analysis is performed, and transplant recipient surgery is initiated (if pathologic analysis satisfactory). Cold ischemia with delay for pathology will have minimal functional impact in this setting based on extensive prior experience with renal transplantation where kidneys are routinely kept hypothermic for several hours prior to transplantation.

Kidney Transplantation

Radical nephrectomy consists of the removal of the kidney together with the perirenal fat and regional lymph nodes. The transperitoneal approach allows early control of the renal vessels.

Laparoscopic Radical Nephrectomy

Mohamed Eltemamy, MD

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 2 cycles. Patients then undergo partial or radical nephrectomy 7-28 days later. Patients then receive nivolumab over 30 IV on day 1. Treatment repeats every 14 days for 6 cycles, and then every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.

Patients enrolled after Amendment 4 receive nivolumab IV over 30 minutes on day 1. Patients then undergo partial or radical nephrectomy 7-28 days later. Patient then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity.

Nivolumab

Quality-of-Life Assessment

Questionnaire Administration

Patients undergo partial or radical nephrectomy within 8 weeks after registration followed by observation.

Patient Observation

Renal denervation (RDN) was performed using radiofrequency ablation in the cardiac catheterization laboratory equipped with a digital subtraction angiography (DSA) system. Under intravenous anesthesia, femoral artery access was obtained and a renal denervation sheath was advanced. An ablation catheter was then introduced to both renal arteries, and ablations were applied across four quadrants to achieve circumferential denervation. Throughout the procedure, vital signs were continuously monitored, and vasodilators or anticholinergics (e.g., nitroglycerin, atropine) were prepared to prevent vascular spasm or related complications. After completion, the femoral access site was closed and compressed, and patients were returned to the ward following stabilization of vital signs.

Renal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN.

Renal Angiography

Yi Zhang

Surgery after induction therapy with IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination.

Partial or complete nephrectomy by open, laparoscopic, or robotic approach.

Cytoreductive nephrectomy

Tumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.

Tissue sampling

Induction therapy wih IO/IO or a TKI/IO-combination, followed by maintenance therapy with nivolumab or a TKI/IO-combination.

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

신장절제술, 수니티닙 단독

교육 및 참여, 교육 및 참여 플러스 신장 지원 치료 프로그램

신장 신경 자극

신장, 체중 및 혈압 측정 절차 개선

초음파 국소화 현미경(ULM), 초음파 국소화 현미경(ULM), 혈액 샘플, 혈액 샘플, 소변 검사, 소변 검사, 신장 초음파 검사, 신장 초음파 검사

신장 교감신경 차단술

신장 변성

CommunityRx-만성 신장 질환

만성 신장 질환(CKD) 검사 결과 전달 도구

기증자 근치적 및 부분적 신절제술, 신장 이식, 복강경 근치적 신절제술

신장절제술, 니볼루맙, 환자 관찰, 삶의 질 평가, 설문 조사 실시

신장 신경차단술, 신장 혈관조영술

세포감소 신장절제술, 조직 샘플링