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20 Diabetic Kidney Disease Trials
Power is an online platform that helps thousands of Diabetic Kidney Disease patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Sotagliflozin for Diabetic Kidney Disease
Cleveland, OhioPowerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, DKA History, Others
Must Be Taking:Insulin, RASB
150 Participants Needed
Genetic Test for Cardiorenal Complications in Type 2 Diabetes
Montreal, QuebecThe goal of this pragmatic trial is to provide Real World Evidence (RWE) on the impact of the result of a polygenic risk prediction test of cardiorenal complications of T2D, so that more patients at high risk of these complications achieve over an 18 months period, recommended therapeutic targets.
This will be demonstrated as a significant improvement in a composite value including HbA1c or systolic blood pressure (SBP) or albuminuria (UACR), or glomerular filtration rate (GFR) lowering.
Researchers will compare the recommended therapeutic targets of uninformed and informed patients to see if the knowledge of the risk by the patients and their treating physicians improves achievement of these targets.
Participants will:
Have a saliva sampling to determine the genetic risk. Visit the clinic once every 3 months for checkups and tests Answer two questionnaires on quality of life.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:High Frailty Index, Others
2714 Participants Needed
WAL0921 for Kidney Disease
Tamarac, FloridaThis is an adaptive prospective, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of WAL0921 in subjects with glomerular kidney disease and proteinuria, including diabetic nephropathy and rare glomerular kidney diseases (primary focal segmental glomerulosclerosis \[FSGS\], treatment-resistant minimal change disease \[TR MCD\], primary immunoglobulin A nephropathy \[IgAN\], and primary membranous nephropathy \[PMN\]). Subjects in this study will be randomized to receive the investigational drug WAL0921 or placebo as an intravenous infusion once every 2 weeks for 7 total infusions. All subjects will be followed for 24 weeks after their last infusion.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 75
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Organ Transplant, Substance Use, Others
96 Participants Needed
Semaglutide for Diabetic Kidney Disease in Type 1 Diabetes
Toronto, OntarioThe primary objective of this study is to determine the effects of semaglutide on kidney oxygenation and function in type 1 diabetes. The secondary objective is to determine the glycemic effects and safety of semaglutide in type 1 diabetes.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 2 Diabetes, Thyroid Carcinoma, Pancreatitis, Others
Must Be Taking:Blood Pressure Drugs, Lipid-lowering Drugs
60 Participants Needed
The aim of this study is to test the hypothesis that sotagliflozin (SGLT1/2 inhibitor) and ambrisentan (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Age:18 - 65
Sex:All
36 Participants Needed
Empagliflozin for Kidney Disease
Washington, District of ColumbiaPrimary Objective:To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease(NDKD), on empagliflozin therapy.
Primary Endpoint: Assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein.
Secondary Objective:
1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR.
2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation.
3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:19 - 90
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Smoking, Pregnancy, Others
Must Be Taking:Empagliflozin
60 Participants Needed
Canagliflozin for Diabetic Kidney Disease
Ann Arbor, MichiganThis trial is testing Canagliflozin, a medication that helps remove sugar from the body through urine, on adults with Type 2 diabetes and early kidney disease. The goal is to see if it can protect their kidney function by lowering blood sugar levels.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Liver Disorders, Cardiovascular Disease, Cancer, Pregnancy, Others
Must Be Taking:RAAS Inhibitors, GLP-1 Agonists
20 Participants Needed
Lorundrostat + Dapagliflozin for Kidney Disease
Pontiac, MichiganThis is a randomized, double-blind (DB), placebo controlled, crossover study with a two-period, two-sequence (2x2) design evaluating the efficacy and safety of 25 mg QD lorundrostat (an aldosterone synthase inhibitor \[ASI\]) in addition to a SGLT2i for the treatment of hypertension in subjects with CKD and albuminuria while receiving stable treatment with an Angiotensin-converting enzyme inhibitor (ACEi) or an Angiotensin receptor blocker (ARB). Subjects will be at least 18 years old with hypertension, and mild to severe CKD with albuminuria at the Screening Visit.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
60 Participants Needed
REACT for Chronic Kidney Disease
Boise, IdahoThe purpose of this study is to evaluate the safety of supplemental REACT injections in participants with chronic kidney disease (CKD) who have previously received REACT treatment.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:30 - 80
Sex:All
10 Participants Needed
NAD Augmentation for Diabetic Kidney Disease
Boston, MassachusettsThis trial is testing whether NMN, a compound that may improve cell function, can help older adults with type 2 diabetes and high urine protein levels. The goal is to see if NMN can reduce kidney damage by improving cell energy production. Participants will receive NMN to compare the effects.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:60+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular Event, Substance Use, Others
Must Be Taking:ACE Inhibitors, ARBs
140 Participants Needed
Empagliflozin for Dialysis Patients with Kidney Failure
Salt Lake City, UtahThe purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Malignancy, Pregnancy, Others
75 Participants Needed
Combo Diabetes Drug for Type 2 Diabetes
Nashville, TennesseePRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:40 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Pancreatitis, Heart Failure, Others
Must Be Taking:SGLT2i, GLP-1 RA
6000 Participants Needed
Basic Needs Navigation for Diabetic Kidney Disease
Milwaukee, WisconsinThe overarching goal of this proposal is to test the feasibility of a basic needs navigation intervention on improving clinical outcomes, self-care behaviors and quality of life in low-income African Americans with diabetic kidney disease (DKD) experiencing multidimensional adversity.
The study objective will be achieved with the following aims:
Aim 1: To determine the feasibility of a basic needs navigation intervention as measured by recruitment, session attendance and retention in low-income Africans Americans with DKD experiencing multidimensional adversity.
Aim 2: To determine the frequency and compounding nature of different basic needs in Africans Americans with DKD experiencing multidimensional adversity to help refine the basic needs navigation intervention.
Aim 3: To evaluate the change and variability in the clinical outcomes (hemoglobin A1c, blood pressure, lipids) at 6 months of follow-up to plan for larger trial.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Active Psychosis, Alcohol/drug Abuse, Others
50 Participants Needed
Metformin + Automated Insulin Delivery for Type 1 Diabetes
Aurora, ColoradoThis trial tests a device that automatically adjusts insulin levels and a medication called metformin in young people with type 1 diabetes. The goal is to see if this combination can better manage blood sugar and improve heart and kidney health. The use of metformin along with insulin therapy has been suggested as a means of improving diabetes control and alleviating weight gain in type 1 diabetes.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:12 - 25
Sex:All
Key Eligibility Criteria
Disqualifiers:Hypertension, Anemia, Kidney Disease, Others
Must Be Taking:Insulin
60 Participants Needed
Fenofibrate for Type 1 Diabetes
Ann Arbor, MichiganDiabetic kidney disease remains the leading cause of end-stage kidney disease (ESKD), rising in frequency in parallel with the epidemic of diabetes worldwide. The estimated lifetime risk of kidney disease in persons with type 1 diabetes (T1D) has been reported to be as high as 50-70%, although risk may be lower in excellent care environments. Two previous studies have suggested that a generic drug used to lower fats in blood (fenofibrate) may protect the kidney from damage due to diabetes. These data, however, were obtained among people with type 2 diabetes with clinical characteristics optimized for cardiovascular studies. Thus, a clinical trial specifically designed to evaluate the effects on the kidney is required to firmly show that this drug can prevent kidney damage in T1D. The goals of the present pilot study are to demonstrate the feasibility of such trial, gather essential information for designing and planning this study, and generate preliminary data. To this end, 40 participants with T1D and early-to-moderate diabetic kidney disease (DKD), at high risk of ESKD, will be enrolled at two clinical sites and assigned in a 1:1 ratio to treatment with fenofibrate or placebo for 18 months. Kidney function will be measured at the beginning and at the end of the study to evaluate the effect of fenofibrate.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 70
Sex:All
40 Participants Needed
Stem Cell Therapy for Chronic Kidney Disease
Rochester, MinnesotaThis trial is testing if using donor stem cells is safe and tolerable for people with chronic kidney disease. The stem cells might help repair their damaged kidneys. Stem cell therapy has shown potential in treating kidney diseases and aiding in kidney regeneration.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1
Age:30 - 80
Sex:All
10 Participants Needed
Finerenone for Chronic Kidney Disease
Cleveland, OhioThis trial is testing finerenone, a daily pill, to help people with non-diabetic chronic kidney disease. Finerenone works by blocking a hormone called aldosterone that can cause damage and swelling in the heart and kidneys. The goal is to see if finerenone can slow down the worsening of kidney disease. Finerenone has shown promise in reducing kidney disease progression in patients with chronic kidney disease and type 2 diabetes.
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:18+
Sex:All
1584 Participants Needed
Atrasentan for Kidney Disease
Hinsdale, IllinoisThis trial is testing a pill called atrasentan that may help people with certain kidney diseases by reducing harmful protein levels in their urine. It targets patients whose kidney function is getting worse despite standard treatments. The goal is to see if this medication can protect their kidneys.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18+
Sex:All
103 Participants Needed
Pentoxifylline for Diabetic Kidney Disease
Cincinnati, OhioPentoxifylline (PTX) is a medication that has been on the market since 1984 for use in disease in the blood vessels of the legs. There is some preliminary information that it may protect the kidneys from damage due to diabetes and other diseases. "Pentoxifylline in Diabetic Kidney Disease" is a study to bee conducted in 40 VA hospitals across the nation to determine definitively whether or not PTX can prevent worsening of kidney disease and delay death in patients with diabetic kidney disease.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, Organ Transplant, Others
Must Not Be Taking:Pentoxifylline, Ketorolac, Riociguat
2510 Participants Needed
Surgical vs. Lifestyle Interventions for Type 2 Diabetes
Pittsburgh, PennsylvaniaThis research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients.
T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:25 - 55
Sex:All
69 Participants Needed
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Frequently Asked Questions
How much do Diabetic Kidney Disease clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Diabetic Kidney Disease clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Diabetic Kidney Disease trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Diabetic Kidney Disease is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Diabetic Kidney Disease medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Diabetic Kidney Disease clinical trials ?
Most recently, we added Sotagliflozin for Diabetic Kidney Disease, Genetic Test for Cardiorenal Complications in Type 2 Diabetes and WAL0921 for Kidney Disease to the Power online platform.
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