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Bicarbonate Administration and Cognitive Function in Midlife and Older Adults with CKD
This study is a 52 week intervention with visits at the Renal Research Office on the University of Colorado Anschutz Medical Campus. Visits will include blood pressure checks, blood and urine collection, measurement of brain blood flow, measurement of cognitive function, and assessment... Protocol #: 20-1672 |
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The short-chain fatty acid acetate for improving age-associated arterial dysfunction
Specific Aim: To determine the following before and after 12 weeks of oral supplementation with calcium acetate vs. placebo (calcium citrate) in healthy men and women 50+ years of age: a) Endothelium-dependent dilation, assessed as brachial artery flow-mediated dilation (FMDBA) [primary o... Protocol #: 22-0473 |
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EVALUATION OF PATIENT OUTCOMES FROM THE KIDNEY ALLOGRAFT OUTCOMES ALLOSURE REGISTRY (KOAR)
This is a multicenter, non-blinded, prospective observational cohort study of 1000 patients enrolled in an AlloSure testing registry, including 300 patients at centers with planned renal surveillance biopsies at 12 months post-transplantation. The other 700 patients will be from centers th... Protocol #: 17-2267 Location: University of Colorado Hospital |
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Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary Thromboendoarterectomy
This is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at we... Protocol #: 17-2349 Location: Outpatient CTRC, University of Colorado Hospital |
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PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)
This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another ... Protocol #: 18-0761 Location: University of Colorado Hospital |
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A Randomized, Placebo-Controlled, Phase 2 Study of HB-101, a Bivalent Cytomegalovirus (CMV) Vaccine, in CMV-Seronegative Recipient (R-) Patients Awaiting Kidney Transplantation from Living CMV-Seropositive Donors (D+)
This is a randomized, placebo-controlled, Phase 2 study of HB-101, a bivalent CMV vaccine, in CMV-seronegative recipient (R-) patients awaiting kidney transplantation from living CMV-seropositive donors (D+). The study population of the study is adult CMV seronegative (-) patients awaiting... Protocol #: 18-1003 Location: Outpatient CTRC, University of Colorado Hospital |
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A Phase 3b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of TRC101 in Delaying Chronic Kidney Disease Progression in Subjects with Metabolic Acidosis
This study will compare how well the study drug works in slowing the progression of kidney disease and how safe the study drug is when compared to placebo in chronic kidney disease patients with metabolic acidosis. The average duration of the study is anticipated to be about 3.5 years. ... Protocol #: 18-1795 Location: Colorado Research Center, Renal Research Center |
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CLINICAL TRIALS IN ORGAN TRANSPLANTATION
CTOT-21: Treg Adoptive Therapy in Subclinical Inflammation in Kidney Transplantation
This is an open label trial to determine the safety and efficacy of a single dose of autologous polyTregs in renal transplant recipients with SCI in the 3 to 7 months pos-transplant allograft biopsy compared to control patients treated with CNI-based immunosuppression. The efficacy of the ... Protocol #: 18-2679 Location: Outpatient CTRC, University of Colorado Hospital |
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Nicotinamide riboside supplementation for treating arterial stiffness and elevated systolic blood pressure in patients with moderate to severe CKD
This is a 3 month study to determine if nicotinamide riboside (a B vitamin) will improve vascular function. During this study labs, vascular function, ambulatory BP, and office BP will be measured before taking the study drug (nicotinamide riboside/placebo) and again 3 months after daily ... Protocol #: 19-0149 Location: Renal Research Center, University of Colorado Hospital |
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A PIVOTAL PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF CLAZAKIZUMAB FOR THE TREATMENT OF CHRONIC ACTIVE ANTIBODY-MEDIATED REJECTION IN KIDNEY TRANSPLANT RECIPIENTS
This multi-center, randomized, double-blind, parallel-group, placebo-controlled, Phase 3 trial investigates whether clazakizumab (an anti-IL-6 mAb) may be beneficial for the treatment of CABMR in kidney transplant recipients by inhibiting the production of DSA and re-shaping T cell alloimm... Protocol #: 19-0460 Location: Outpatient CTRC, Pathology - SOM, University of Colorado Hospital |
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APOL1 Long-term Kidney Transplantation Outcomes Network
APOLLO is an observational study designed to assess the impact of RRVs in the APOL1 gene on the functional outcomes of kidneys transplanted from living and deceased donors with recent African ancestry and on the kidney function of living kidney donors with recent African ancestry in a pros... Protocol #: 19-0461 Location: University of Colorado Hospital |
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Personalized experiences to inform improved communication for patients with Life Limiting Illness
For Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on pa... Protocol #: 19-1874 Location: University of Colorado Hospital |
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A PHASE 3 TRIAL OF THE EFFICACY AND SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE
Each study subject will be randomized to receive either study drug or placebo for a total of 100 weeks, with the exception of a 4 week period between weeks 48 an 52, where no study drug is taken. Neither the subject nor the study staff will know which treatment was given until after the st... Protocol #: 19-2782 Location: Brain Imaging Center (BIC), Outpatient CTRC, Renal Research Center, University of Colorado Hospital |
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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obinutuzumab in Patients with ISN/RPS 2003 Class III or IV Lupus Nephritis
After a screening period of up to 28 days, eligible subjects will be randomized to receive blinded infusions of obinutuzumab 1000 mg or placebo on Day 1, and weeks 2,24,26,50,52 in three treatment groups. and will be assessed at week 76. Neither the subject or study staff will know which t... Protocol #: 20-0941 Location: Outpatient CTRC, University of Colorado Hospital |
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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
We want to study how feasible it is to restrict eating to 8 hours a day. Both groups will participate in a group-based, behavioral dietary intervention for 1 year (initially weekly, then monthly meetings). We will also look at changes in markers in the blood and both the size of the kidn... Protocol #: 20-1262 Location: Anschutz Health and Wellness, Brain Imaging Center (BIC), Renal Research Center, University of Colorado Hospital |
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Clonal hematopoiesis, mild cognitive impairment and kidney function decline.
CH is a common aging-associated biological state that predisposes to subsequent cardiovascular death, however, whether it plays a role in MCI, dementia and kidney disease progression is unknown and understanding this novel risk factor may uncover new ways to reduce the burden of cognitiv... Protocol #: 22-0288 Location: Renal Research Center |
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A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN
ADULT AND ADOLESCENT PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)
SIngle-arm, uncontrolled, multicenter, global Phase III study designed to evaluate the efficacy, immunogenicity, pharmacokinetics, and pharmacodynamics of crovalimab in patieths with aHUS.... Protocol #: 20-2595 Location: Childrens Hospital Colorado |
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Inspiratory Muscle Strength Training for Lowering Systolic Blood Pressure in Midlife and Older Adults with Chronic Kidney Disease
Participants will be instructed in inspiratory muscle strength training (IMST) during baseline and will be evaluated during a 3 month period to see the effects of the device on systolic blood pressure. There will be a "placebo" arm. Participants will not know which arm they are in.... Protocol #: 21-3000 Location: Brain Imaging Center - BIC, University of Colorado Hospital |
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Effect of Alkali Therapy on Vascular and Graft Function in Kidney Transplant Recipients
Participation will last approximately 52 weeks and will include 3-7 in-person visits. Baseline, Month 6, and Month 12 visits will be held in person to assess blood vessel health. Baseline visits will be coordinated with patients' 1 year post-transplant biopsy. The Month 12 biopsy wil... Protocol #: 21-3447 Location: Renal Research Center, University of Colorado Hospital |
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A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in
Infants and Children at Increased Risk for Severe RSV Disease
This trial is testing a study medicine to learn if it can help prevent RSV infection in babies who are more likely to get severe RSV illness. Infants will be randomized to receive either Synagis or the study drug. There are approximately 3 blood draws per season, and participants will be ... Protocol #: 21-4176 Location: Childrens Hospital Colorado |
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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Phase 3 Study to Investigate the Efficacy and Safety of FInerenone, in Addition to Standard of Care, on the Progression of Kidney Disease in Patients with Non-Diabetic Chronic Kidney Disease
Trial to examine: -the impact of Finerenone vs. Placebo in delaying the progression of kidney disease. -the safety of Finerenone vs. Placebo in addition to standard of care treatment -quality of life measures via survey This trial will include 1580 participants worldwide. Stu... Protocol #: 21-4551 Location: Renal Research Center |
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Feasibility study of empagliflozin in patients with autosomal dominant polycystic kidney disease
Participation involves taking the study drug empagliflozin or a placebo for 12 months. Blood sample collection, magnetic resonance imaging (MRI) of the kidneys and blood vessel stiffness testing during visits at baseline, 3-month and 12-month to the Renal Research Clinic located at the... Protocol #: 22-0616 Location: Brain Imaging Center (BIC), Brain Imaging Center - BIC, Renal Research Center, University of Colorado Hospital |