Clinical Trials

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37 studies in Division of Nephrology and Hypertension

  1. Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

    Rochester, Minn. View Summary

    Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Idiopathic Nephrotic Syndrome (NS) is a rare disease syndrome responsible for approximately 12% of all causes of end-stage kidney disease (ESRD) and up to 20% of ESRD in children. Treatment strategies for Focal and Segmental Glomerulosclerosis (FSGS), Minimal Change Disease (MCD) and Membranous Nephropathy (MN), the major causes of NS, include high dose prolonged steroid therapy, cyclophosphamide, cyclosporine A, tacrolimus, mycophenolate mofetil and other immunosuppressive agents, which all carry significant side effects. Failure to obtain remission using the current treatment approaches frequently results in progression to ESRD with its associated costs, morbidities, and mortality. In the North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS) registry, half of the pediatric patients with Steroid Resistant Nephrotic Syndrome required renal replacement therapy within two years of being enrolled in the disease registry. FSGS also has a high recurrence rate following kidney transplantation (30-40%) and is the most common recurrent disease leading to allograft loss. The prevailing classification of Nephrotic Syndrome categorizes patients into FSGS, MCD, and MN, if in the absence of other underlying causes, glomerular histology shows a specific histological pattern. This classification does not adequately predict the heterogeneous natural history of patients with FSGS, MCD, and MN. Major advances in understanding the pathogenesis of FSGS and MCD have come over the last ten years from the identification of several mutated genes responsible for causing Steroid Resistant Nephrotic Syndrome (SRNS) presenting with FSGS or MCD histopathology in humans and model organisms. These functionally distinct genetic disorders can present with indistinguishable FSGS lesions on histology confirming the presence of heterogeneous pathogenic mechanisms under the current histological diagnoses. The limited understanding of FSGS, MCD, and MN biology in humans has necessitated a descriptive classification system in which heterogeneous disorders are grouped together. This invariably consigns these heterogeneous patients to the same therapeutic approaches, which use blunt immunosuppressive drugs that lack a clear biological basis, are often not beneficial, and are complicated by significant toxicity. The foregoing shortcomings make a strong case that concerted and innovative investigational strategies combining basic science, translational, and clinical methods should be employed to study FSGS, MCD, and MN. It is for these reasons that the Nephrotic Syndrome Study Network is established to conduct clinical and translational research in patients with FSGS/MCD and MN.

    NCT ID:

    NCT01209000

    Who can I contact for additional information about this study?

    Rochester: Lori Riess 507-266-1047
                        Shirley Jennison 507-255-0231


  2. Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

    Rochester, Minn. View Summary

    Use of Tolvaptan to Reduce Urinary Supersaturation: a Pilot Proof of Principle Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In this study the investigators propose to use a daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM). This relatively small well-tolerated dose is likely to persistently increase urine volume and reduce urine supersaturation and to be well tolerated by patients with kidney stone disease and normal renal function (see below). The twice-daily (8 AM and 4 PM) regimen is designed to produce a maximal AVP inhibition on waking with a gradual fall-off of effect during the night. To this end, a higher dose is used in the morning, with a lower dose in the afternoon.

    NCT ID:

    NCT02096965

    IRB Number:

    11-001780

    Who can I contact for additional information about this study?

    Rochester: Ruth A. Kraft, Research Coordinator 507-266-8133
                        


  3. Clinical Trial to Slow the Progression of ADPKD

    Rochester, Minn. View Summary

    Clinical Trial to Slow the Progression of ADPKD

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This study will determine whether certain blood pressure medications will slow cyst growth or keep kidneys functioning longer in patients with autosomal dominant polycystic kidney disease (ADPKD). The study will take place at several sites in the United States. The start date of the study has not yet been determined.

    NCT ID:

    NCT00067977

    Who can I contact for additional information about this study?

    Rochester: 507-284-0944
                        


  4. Screening for Dent Disease Mutations in Patients With Proteinuria

    Rochester, Minn. View Summary

    Screening for Dent Disease Mutations in Patients With Proteinuria

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    During this study visit, the investigator will draw one tube, about two teaspoonfuls (1 to 1 ½ teaspoons for children), of blood from your arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing. We will use the isolated DNA to try to identify the gene that is defective in Dent Disease by comparing it with the structure of genes in normal individuals, patients with Dent Disease, and family members for Dent Disease.

    NCT ID:

    NCT01783795

    IRB Number:

    10-006442

    Who can I contact for additional information about this study?

    Rochester: Barbara M Seide 507-255-0387
                        Mayo Clinic Hyperoxaluria Center 800-270-4637


  5. A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

    Rochester, Minn., Phoenix/Scottsdale, Ariz. View Summary

    A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

    Location:

    Rochester, Minn., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

    NCT ID:

    NCT01865747

    IRB Number:

    13-003958

    Who can I contact for additional information about this study?

  6. Role Of Phosphorus And FGF 23 In Patients With Dent Disease

    Rochester, Minn. View Summary

    Role Of Phosphorus And FGF 23 In Patients With Dent Disease

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Patients with Dent disease have suppressed levels of FGF 23 which contributes to hypercalciuria, kidney stones, nephrocalcinosis and renal failure. Supplementation with phosphorus may reduce hypercalciuria.

    NCT ID:

    NCT02016235

    IRB Number:

    13-004774

    Who can I contact for additional information about this study?

    Rochester: Barbara Siede 800-270-4637
                        Alicia M Meek 800-270-4637


  7. Multi-center Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

    Rochester, Minn. View Summary

    Multi-center Study of Metastatic Lung Tumors Targeted by Interventional Cryoablation Evaluation

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Treatment for pulmonary metastatic disease may include surgery, chemotherapy, radiation therapy, or a combination of treatments. However, several variables may exclude patients from these treatments such as multiple tumors, multiple previous surgeries, pulmonary dysfunction, or co-morbid medical conditions. For these patients, percutaneous cryoablation may be a suitable option. Ablation of metastatic lung tumors is a rapidly expanding area within interventional oncology. Cryotherapy, radiofrequency, laser and microwave have all been shown to be effective. Cryotherapy offers a wide range of anatomic and tumor treatment options because of the ability to visualize the ice under imaging guidance and the preservation of collagenous tissue structure. Cryoablation has been extensively performed in the prostate and kidney with favorable outcomes reported in the literature. More recently, cryoablation has been shown to be safe in the treatment of lung tumors with CT guidance.

    NCT ID:

    NCT01957787

    IRB Number:

    13-007655

    Who can I contact for additional information about this study?

    Rochester: Connie Sathre 507-538-0540
                        


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