Clinical Trials

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24 studies in Division of Nephrology and Hypertension

  1. A Phase 2 Open-label Multi-centre Study to Evaluate the Efficacy and Safety of Oxabact® to Reduce Plasma Oxalate in Subjects With Primary Hyperoxaluria Who Are on Dialysis
    Rochester, Minn. View Summary

    A Phase 2 Open-label Multi-centre Study to Evaluate the Efficacy and Safety of Oxabact® to Reduce Plasma Oxalate in Subjects With Primary Hyperoxaluria Who Are on Dialysis

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.

    NCT ID:

    NCT02000219

    IRB Number:

    13-009042

    Who can I contact for additional information about this study?

    Rochester: Tamara Evans 507-284-1004
                        


  2. Renal Mass Registry
    Phoenix/Scottsdale, Ariz. View Summary

    Renal Mass Registry

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    RCC is a cancer that is poorly understood. The increase in both incidence and mortality rates for RCC, coupled with the lack of effective therapies for RCC beyond surgical excision, underscore the need for a better understanding of RCC tumor biology, immunology, and epidemiology. Such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. Recently, the National Cancer Institute's Kidney Cancer Progress Review Group identified as top priorities for future research the need to "better understand the mechanisms underlying known risk factors for kidney cancer" and "examine tumor tissue to identify predictors of patient outcome and targets for therapy". In addition, the review group stressed that the leaders in renal cancer research over the next decade would be those institutions that could enroll large numbers of patients, collect valuable risk factor and quality of life data from these patients and harness the latest technology to organize and analyze data.

    NCT ID:

    NCT01887574

    IRB Number:

    13-002688

    Who can I contact for additional information about this study?


    Scottsdale: EriK Castle, MD 480-301-5000
                        

  3. EARLY DETECTION OF BROKEN HEARTS IN CANCER PATIENTS: BEVACIZUMAB, SUNITINIB AND HEART FAILURE
    Rochester, Minn. View Summary

    EARLY DETECTION OF BROKEN HEARTS IN CANCER PATIENTS: BEVACIZUMAB, SUNITINIB AND HEART FAILURE

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80 at Mayo Clinic [40 receiving BVZ and 40 receiving Sunitinib] and 20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv every 2-3 weeks for colorectal cancer or Sunitinib 50 mg po daily for advanced Metastatic renal cell carcinoma will be screened for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. At each visit, in addition to standard of care provided by the Oncologist, blood will be drawn to measure high sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and 3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.

    NCT ID:

    NCT02086695

    IRB Number:

    12-005362

    Who can I contact for additional information about this study?

    Rochester: Sharon L Mulvagh, M.D. 507-284-9601
                        


  4. Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function
    Rochester, Minn. View Summary

    Define in Humans With Compensated CHF and Renal Dysfunction, the Modulating Action of Chronic AT1 Receptor Blockade in Addition to ACE Inhibition on Cardiorenal and Humoral Function

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    To advance our understanding of the mechanisms of human cardiorenal syndrome with emphasis upon the interaction of diuretic therapy and the renal-angiotensin-aldosterone -system and cGMP pathway. The belief is that the chronic AT1 receptor blockade in subjects with compensated CHF and renal dysfunction will improve renal function with increased sodium excretion, glomerular filtration rate and effective renal plasma flow and renal function reserve as compared to the response of placebo-treated subjects.

    NCT ID:

    NCT01678794

    IRB Number:

    09-003284

    Who can I contact for additional information about this study?

    Rochester: Lynn Harstad 507-284-4838
                        


  5. Renal Tumors Classification, Biology, and Banking Study
    Rochester, Minn. View Summary

    Renal Tumors Classification, Biology, and Banking Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies. II. Maintain a biological samples bank to make specimens available to scientists to evaluate additional potential biological prognostic variables and for the conduct of other research by scientists. SECONDARY OBJECTIVES: I. Monitor outcome for those patients who are not eligible for a subsequent therapeutic study. II. Describe whether the pulmonary tumor burden correlates with outcome in patients with stage IV disease. III. Describe the sensitivity and specificity of abdominal computed tomography (CT) scan by comparing it with surgical and pathologic findings for identification of local tumor spread beyond the renal capsule to adjacent muscle and organs, lymph node involvement at the renal hilum and in the retroperitoneum, preoperative tumor rupture, and metastases to the liver. IV. Compare the sensitivity and specificity of pre-operative abdominal CT scan and MRI for the identification and differentiation of nephrogenic rests and Wilms' tumor in children with multiple renal lesions. V. Correlate the method of conception (natural vs assisted reproductive technology) with the development of Wilms' tumor. OUTLINE: This is a multicenter study. Tumor tissue, blood, and urine samples are collected for research studies, including immunohistochemistry. CT scans and magnetic resonance imaging (MRIs) are also performed. Loss of heterozygosity analyses (chromosome 1p and 16q) are performed by extraction of DNA. DNA polymorphisms are assayed by polymerase chain reaction using standard methodology. Leftover specimens are archived for future studies. Patients are followed periodically for 5 years.

    NCT ID:

    NCT00898365

    IRB Number:

    07-000195

    Who can I contact for additional information about this study?

    Rochester: Carola A. Arndt 507-538-7623
                        


  6. Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)
    Rochester, Minn. View Summary

    Xolair (Omalizumab) for Treatment of Drug-induced Acute Tubulointerstitial Nephritis (AIN)

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The investigators goal is to evaluate the role of XOLAIR® in treatment of Acute Tubulointerstitial Nephritis (AIN) with the goal of shortening the duration and dose of prednisone for treatment of drug-induced AIN. Currently there is no good treatment for drug-induced AIN. Prednisone is the standard treatment but is associated with many side-effects when used long-term and at high doses.

    NCT ID:

    NCT01893658

    IRB Number:

    12-006797

    Who can I contact for additional information about this study?

    Rochester: Joanne D. Ryan 507-266-8668
                        Kathleen S. Mieras, CCRP 507-284-9187


  7. Pasireotide LAR in Severe Polycystic Liver Disease
    Rochester, Minn. View Summary

    Pasireotide LAR in Severe Polycystic Liver Disease

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Pasireotide (SOM230) is a novel multi-receptor-targeted analog that has high affinity for four of the five SST receptor subtypes (SSTr1, SSTr2, SSTr3 and SSTr5); it has a 40-fold higher affinity and 158-fold higher functional activity for the SST5 receptor than octreotide. Because of its broad receptor binding profile, pasireotide may be more potent in Polycystic Liver Disease (PLD) than octreotide. In this randomized double blind placebo controlled trial the investigators will compare SOM230 treatment to placebo for 12 months in patients with PLD. The primary endpoints will be assessed at 12 months and patients receiving placebo then crossed over to SOM230, permitting all participants to receive SOM230 for the subsequent two years. Magnetic resonance imaging (MRI) will be used to assess liver volume - the primary endpoint, which will be assessed at baseline, end of years 1 and 3. This study will assess the efficacy and safety of SOM230 in reducing total liver volume and improving quality of life over 12 months. (The investigators will not be assessing efficacy at 24 months.) The therapy way be effective in PLD but also may prove to be effective for many more patients with Polycystic Kidney Disease (PKD) which will be evaluated using eGFR and kidney volume using MRI.

         The investigators plan to add other sub-sites in other locations.

    NCT ID:

    NCT01670110

    IRB Number:

    11-007405

    Who can I contact for additional information about this study?

    Rochester: Angela Ihrke 507-538-2902
                                             Marie C Hogan, MD, PhD 507-284-2500
             
             
           
  8. Biobank Protocol, Rare Diseases Clinical Research Network
    Rochester, Minn. View Summary

    Biobank Protocol, Rare Diseases Clinical Research Network

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Biologic samples will be stored in the biobank from well characterized patients with primary hyperoxaluria, cystinuria, APRT deficiency, and Dent disease, and from their family members, for use in future research. This will help to advance our understanding of disease expression and the factors associated with kidney injury in these four diseases with the overall goal of developing new treatments to preserve kidney function and reduce nephrocalcinosis and stone formation.

    NCT ID:

    NCT02026388

    IRB Number:

    11-005413

    Who can I contact for additional information about this study?

    Rochester: Alicia M Meek 507-255-4347
                        Barbara M Seide 507-255-0387


  9. A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma
    Phoenix/Scottsdale, Ariz. View Summary

    A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a multicenter, open-label, Phase 2 study. Subjects will be randomized to either the investigational product, DN24-02, or to standard of care. The purpose of this study is to compare the length of survival between these 2 groups of subjects. Other purposes of the study are to learn about the safety of DN24-02, to learn if it delays the time until urothelial cancer recurs, and to learn if the immune system responds to treatment with DN24-02. All subjects will be followed for this study for the remainder of their lives.

    NCT ID:

    NCT01353222

    IRB Number:

    11-008919

    Who can I contact for additional information about this study?

  10. Influence of Hydroxyproline Plasma Concentration on Its Metabolism to Oxalate
    Rochester, Minn. View Summary

    Influence of Hydroxyproline Plasma Concentration on Its Metabolism to Oxalate

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    The purpose of this study is to determine the contribution of hydroxyproline metabolism to urinary oxalate and glycolate excretion in patients with primary hyperoxaluria. Oxalic acid (COOH)2 is an end product of metabolism that is synthesized mainly in the liver. We have estimated that 10 - 20 mg is synthesized in the body of healthy adults each day (1). The main precursor of oxalate is glyoxylate (CHO•COOH). The bulk of the glyoxylate formed is normally transaminated to glycine (NH2•CH2•COOH) by alanine: lyoxylate aminotransferase (AGT) or reduced to glycolate (CHOH•COOH) by glyoxylate reductase (GR). Less than 10% of the glyoxylate is oxidized to oxalate by lactate dehydrogenase (LDH). In individuals with the disease, primary hyperoxaluria, AGT, GR, or HOGA enzyme is deficient and the amount of oxalate synthesized by the liver increases to 80 - 300 mg per day. The increased oxalate excreted in urine can cause damage to kidney tissue. Calcium oxalate stones may form in the kidney or calcium oxalate crystals may deposit in renal tubules and the renal parenchyma (nephrocalcinosis). An increased rate of oxalate synthesis could also contribute to idiopathic calcium oxalate stone disease. Understanding the pathways of endogenous oxalate synthesis and identifying strategies that decrease oxalate production could be beneficial for individuals with these diseases. Hydroxyproline is the primary source of glyoxylate identified in the body (2). Daily collagen turnover of bone results in the formation of 300 - 450 mg of hydroxyproline, which cannot be re-utilized by the body and is broken down. This metabolism yields 180 - 250 mg of glyoxylate. Further hydroxyproline is obtained from the diet, primarily from meat and gelatin-containing products. The bulk of the glyoxylate formed is converted to glycine by the liver enzyme AGT, some to glycolate and a small amount to oxalate. The proportion of these metabolites is not known with any certainty. In this study, a quantitative estimate of the metabolites formed will provide estimates of the contribution of hydroxyproline turnover to daily oxalate production. These experiments will provide valuable information for the future assessment of the contribution of hydroxyproline metabolism to oxalate production in individuals with primary hyperoxaluria.

    NCT ID:

    NCT02038543

    IRB Number:

    13-000150

    Who can I contact for additional information about this study?

    Rochester: Julie B Olson, RN 800-270-4637
                        


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