Clinical Trials

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39 studies in Division of Nephrology and Hypertension

  1. An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

    Phoenix/Scottsdale, Ariz. View Summary

    An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

    NCT ID:

    NCT01582672

    IRB Number:

    13-000333 13-006506

    Who can I contact for additional information about this study?

  2. 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


  3. "A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"

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

    "A Randomized Controlled Trial of Rituximab Versus Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy (IMN)"

    Location:

    Rochester, Minn., Jacksonville, Fla., Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In IMN, experimental data suggests that B cells are involved in the pathogenesis of the disease. To date, the best proven therapy for patients with MN consists of the combined use of corticosteroids and cyclophosphamide (CYC). Since the mechanism of action of CYC includes suppression of various stages of the B cell cycle including B cell activation, proliferation, and differentiation and inhibition of immunoglobulin secretion, it lends credence to the hypothesis that B cells abnormalities are involved in the pathogenesis of MN. Given the key role of IgG antibodies in MN, it is reasonable to postulate that suppression of antibody production by depleting B cells may improve or even resolve the glomerular pathology and be reflected by a reduction in proteinuria. Thus, a case could be made for using an agent capable of selectively depleting B cells, and therefore halting the production of immunoglobulins against antigens potentially present in the glomeruli. This approach could stop the initiating sequence of pathogenic events and result in resolution of the. The P.I. believes that the application of selective B cell targeting with Rituximab (RTX) will prove at least equal, or even superior, both in the production of short term and long term control of the NS and be safer than any current therapeutic regimen used to treat MN. Based on this rationale, we conducted a pilot trial in 15 newly-biopsied patients (<3 years) with IMN and proteinuria >5g/24h despite ACEi/ARB use for >3months and systolic BP <130mmHg. Mean baseline creatinine was 1.4 mg/dl. Thirteen males and 2 females, median age 47 (range 33-63), were treated with RTX (1g) on days 1 and 15. At six months, patients who remained with proteinuria >3g/24 received a second identical course of RTX. Baseline proteinuria of 13.0±5.7g/24h (range 8.4-23.5) decreased to 6.0±7.0 g/24h (range 0.2-20) at 12 months (mean ± SD). In the fourteen patients who completed a 12 months follow-up complete remission (proteinuria <0.3g/24h) was achieved in 2 patients and partial remission (<3g/24h) in 7 patients. In 5 of these 7 patients, proteinuria was <1.5g/24h and follow up at 18 months showed that 3 of these 7 patients on PR achieved CR of proteinuria. Five patients did not respond. The mean drop in proteinuria from baseline to 12 months was 6.2± 5.1g (p=.002, paired t-test). There were a limited number of minor side-effects. Initial CD20+ B cell depletion was seen in all patients. However, at 3 months, CD20+ B cells were starting to recover with five patients >35 cells/µl (range 35-152).(50) These data contrasts with previous work by Ruggenenti et al. using RTX given weekly (375 mg/m2) for 4 weeks. Pharmacokinetic (PK) analysis showed that RTX levels in this 2-dose regimen were 50% lower compared to non-proteinuric patients, which could potentially result in undertreatment. Based on these results, we recently conducted a study postulating that in patients with MN, 4 weekly doses of RTX would result in more effective B cell depletion, a higher remission rate and maintaining of the same safety profile compared to patients treated with RTX dosed at 1g x 2. Twenty patients (11 failures to prior therapy) with MN and proteinuria >5g/24h received RTX (375mg/m2 x 4), with retreatment at 6 months regardless of proteinuria response. A detailed PK was conducted simultaneously along with immunological analyses of the adaptive immune compartment (T and B cells) to ascertain the impact of RTX on lymphocyte subpopulations. Baseline proteinuria of 11.9±4.9g/24h decreased to 4.2±3.8g/24h and 2.0±1.7g/24h at 12 and 24 months, respectively (p<0.001) while creatinine clearance increased from 72.4±33 at baseline to 88.4 ±31.5 ml/min/1.73m2 at 24 months (p=0.02). Of 18 patients who completed 24-months follow up, 4 are in complete remission, 12 are in partial remission (CR + PR = 80%), 1 has a limited response (>50% drop in P but >3.5g/24h) and 1 patient relapsed. When interpreting these results we should take into account that >50% of these patients had failed previous immunosuppressive therapy. This study also emphasizes that proteinuria is reduced gradually and may take several months to reach its nadir an observation that is in agreement with previous reports in patients with MN treated with prednisone in combination with a cytotoxic agent but without the short-term toxicity seen with alkylating agents. Kidney function remained stable or improved in all patients. Serum RTX levels were similar to those obtained with 2 doses of RTX. Four 4 doses of RTX did result in more effective B cell depletion but proteinuria reduction was basically identical to the results obtained using RTX 1000mg on days 1 and 15. Thus, we believe that this particular dosing regimen with retreatment at 6 months should be used in a randomized-control trial comparing RTX to Cyclosporine (the standard of care for IMN in the US). We believe that RTX will prove equal or superior to Cyclosporine in the treatment of MN and could represent the new standard of care for patients with this disease

    NCT ID:

    NCT01180036

    IRB Number:

    10-003372

    Who can I contact for additional information about this study?

    Rochester: Lori A Riess 507-266-1047
                        Shirley A Jennison 507-255-0231
    Scottsdale: Leslie F. Thomas, M.D. 480-342-0161
                        Andrea L. Francone, R.N. 480-342-1258
    Jacksonville: Nabeel Aslam, MD 904-953-7259
                        Jonathan J. Wright, MHSc, CCRP 904-953-7521
  4. A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

    Rochester, Minn. View Summary

    A Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily. The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.

    NCT ID:

    NCT01841762

    IRB Number:

    13-002142

    Who can I contact for additional information about this study?

    Rochester: Robert Frantz 507-284-2511
                        LuAnne Koenig (507) 284-4298
    Scottsdale: Robert L Scott 480-342-2376
                        Arcenio Galindo (480) 342-3987
    Jacksonville: Charles Burger 904-953-2000
                        Shannon Kennedy (904) 953-8557
  5. A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

    Phoenix/Scottsdale, Ariz. View Summary

    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

    Location:

    Phoenix/Scottsdale, Ariz.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Subjects will be followed for one year after first study drug injection. This is the primary study period. Subjects will be followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

    NCT ID:

    NCT01974206

    IRB Number:

    13-007314

    Who can I contact for additional information about this study?

  6. 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
                        


  7. Systematic Review of Clinical Biopsies of Dent Disease Patients

    Rochester, Minn. View Summary

    Systematic Review of Clinical Biopsies of Dent Disease Patients

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    If the patient agrees to be in the study, the patient will be asked to participate in the following: - Sign a consent form indicating the patient's willingness to participate. - Provide a signed medical release form allowing the investigator to request your official kidney biopsy reports, and also allowing the investigator to request the original slides for review. At the end of the study, all slides will be returned to the referring facility. - The investigator will also review your medical record

    NCT ID:

    NCT02022189

    IRB Number:

    13-003738

    Who can I contact for additional information about this study?

    Rochester: Alicia M Meek 507-255-4347
                        Mayo Clinic Rare Kidney Stone Consortium 800-270-4637


  8. Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

    Rochester, Minn. View Summary

    Randomized, Double-Blind Phase III Study of Pazopanib vs. Placebo in Patients With Metastatic Renal Cell Carcinoma Who Have No Evidence of Disease Following Metastatectomy

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    PRIMARY OBJECTIVES: I. To evaluate disease-free survival with pazopanib (pazopanib hydrochloride) as compared to placebo, defined as the time from randomization to the development of recurrent disease, second primary cancer (other than localized breast, localized prostate, or non-melanoma skin cancer) or death from any cause for patients with metastatic renal cell carcinoma (RCC) with no evidence of disease following metastatectomy. SECONDARY OBJECTIVES: I. To describe the overall survival of patients with advanced RCC randomly assigned to receive placebo or pazopanib for one year following metastatectomy to no evidence of disease (NED). II. To describe treatment- and (at recurrence) disease-related adverse events in the two treatment arms. III. To analyze quality-adjusted time without symptoms of disease or treatment (Q-TWiST) for subjects in the two treatment arms. IV. To characterize changes in patient-reported fatigue and (at recurrence) kidney cancer-related symptoms during and following treatment with pazopanib compared to placebo. V. To explore the association between plasma trough levels of pazopanib and disease-free and overall survival. VI. To prospectively bank preserved tissue from primary tumors and associated metastatic sites in patients with RCC. OUTLINE: Patients are randomized to 1of 2 treatment arms. ARM I: Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo PO QD on days 1-28. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for the first two years, every 6 months for the next 3 years, and then annually through 10 years.

    NCT ID:

    NCT01575548

    IRB Number:

    12-008951

    Who can I contact for additional information about this study?

    Rochester: Brian A. Costello 507-538-7623
                        


  9. An Open-Label Study to Explore the Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching When Used for Treatment of Group 1 Pulmonary Arterial Hypertension in Patients With Concomitant Chronic Obstructive Pulmonary Disease (COPD)

    Jacksonville, Fla. View Summary

    An Open-Label Study to Explore the Impact of Inhaled Treprostinil Sodium on Ventilation Perfusion Matching When Used for Treatment of Group 1 Pulmonary Arterial Hypertension in Patients With Concomitant Chronic Obstructive Pulmonary Disease (COPD)

    Location:

    Jacksonville, Fla.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    In patients with severe COPD where the FEV1 is 50% or less than predicted, emphysema and obliterating bronchiolitis presenting a "ceiling" to any improvement in function that can be achieved by therapies that dilate the airways or lessen inflammation. Such severe COPD is commonly associated with pulmonary hypertension at rest or during exercise. Although hypoxia has been classically considered to be the major pathogenic mechanism of pulmonary hypertension in COPD and oxygen has been the mainstay of therapy, other mechanisms may play important roles. Indeed, endothelial dysfunction can be observed in patients with mild to moderate COPD who do not have hypoxemia and in smokers with normal lung function. In addition, long-term oxygen therapy does not generally result in resolution of the pulmonary hypertension. A key question that remains is whether the newer therapies for pulmonary arterial hypertension (PAH) could improve pulmonary hypertension and therefore exercise tolerance in COPD. Unfortunately the use of non-selective pulmonary vasodilator therapy in oral, intravenous or subcutaneous form for PAH patients who have unrelated concomitant COPD, is known to cause worsening gas exchange and intensification of symptoms despite a decrease in pulmonary vascular resistance and arterial pressures. We hypothesize that an inhaled pulmonary vasodilator may not worsen ventilation-perfusion mismatching by selectively vasodilating well ventilated areas in PAH patients with concomitant COPD and in fact may improve ventilation perfusion matching leading to preservation or improvement of oxygenation.

    NCT ID:

    NCT01494896

    IRB Number:

    11-000743

    Who can I contact for additional information about this study?



    Jacksonville: Pamela Long, RN 904-953-7718
                        Ellen Miceli, RN 904-953-8939
  10. Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study

    Rochester, Minn. View Summary

    Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study

    Location:

    Rochester, Minn.

    Trial status:

    Open for Enrollment

    Why is this study being done?

    Symptomatic atrial fibrillation (AF) refractory to anti-arrhythmic drugs is commonly treated with ablation therapy. Pulmonary vein isolation along with additional substrate medication is commonly performed during ablation procedures is associated with 60-80% success rate for maintenance of sinus rhythm. After AF ablation hypertension (HTN) is a strong predictor for recurrence of atrial fibrillation. Drug resistant hypertension can be effectively treated with catheter based renal denervation therapy. Our primary hypothesis is concomitant renal denervation therapy along with AF ablation is associated with improvement in success rates of AF ablation along with adequate control of blood pressure. The specific objectives of this study are to prospectively compare success rates, time to AF recurrence, AF burden and blood pressure controls in patients randomized to concomitant renal denervation arm when compared to patients with AF ablation alone.

    NCT ID:

    NCT01952743

    IRB Number:

    12-009062

    Who can I contact for additional information about this study?

    Rochester: Siva K. Mulpuru, M.D. 507-255-2398
                        Rajiv Gulati, M.D., Ph.D. 507-538-6325


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