Nephrology-Hypertension Clinical Trials
The following searchable list includes all the Division of General Nephrology-Hypertension - Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.
A PHASE 3 SINGLE CENTER STUDY OF ISLET TRANSPLANTATION IN NON-UREMIC DIABETIC PATIENTS
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determ…
Type 1 diabetes is an autoimmune disease in which the insulin-producing pancreatic beta cells are destroyed, resulting in poor blood sugar control. The purpose of this study is to determine the safety and effectiveness of islet transplantation, combined with immunosuppressive medications, specifically using Campath as induction, for treating type 1 diabetes in individuals experiencing hypoglycemia unawareness and severe hypoglycemic episodes.
Chronic Kidney Disease Research Biorepository
The objective of this study is to create a biorepository of stored blood and urine specimens and demographic and clinical data collected from patients with chronic kidney disease and healthy volunteers for use in chronic kidney disease research
A phase 3 randomized, open-label (sponsor-blind), active controlled, parallel-group, multi-center, event driven study in non-dialysis subjects with anemia associated with chronic kidney disease to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.
This is a phase III study…
This is a phase III study in non-dialysis subjects with anemia associated chronic kidney disease to evaluate the safety and efficacy of an investigational drug, Daprodustat when compared to darbepoetin alfa.
Inclusion Criteria:1. Men or Women 18 to 99 years of age.2. Chronic Kidney Disease Stages 3, 4, or 53. Acceptable if on Erythropoietin-Stimulating Agents4. Hemoglobin between 8 to 12 g/dL5. Willingness to participate and capable of giving signed informed consent.Exclusion Criteria: 1. Currently receiving dialysis2. Planned kidney transplant within 1 year 3. Iron deficient4. Other causes of anemia (pernicious anemia, thalassemia major, sickle cell, myelodysplastic syndrome)5. Uncontrolled high blood pressure6. History of malignancy within 2 years 7. Unstable liver disease8. Chronic Class IV heart failure
Transformative Research In Diabetic Nephropathy (TRIDENT) (SP0043185)
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest b…
This is a prospective, observational, cohort study of patients with a clinical diagnosis of diabetes who are undergoing clinically indicated kidney biopsy. The intent is to collect, process, and study kidney tissue and to harvest blood, urine and genetic materials to elucidate molecular pathways and link them to biomarkers that characterize those patients have a rapid decline in kidney function (> 5 mL/min/1.73m2/year) from those with lesser degrees of kidney function change over the period of observation. High through-put genomic analysis associated with genetic and biomarker testing will serve to identify key potential therapeutic targets for DKD by comparing patients with rapid and slow progression patterns. Each participating clinical site will search for, consent, harvest the biopsy sample, and enroll the participants as required for the TRIDENT protocol.
• Type 1 and 2 Diabetes by ADA criteria (see appendix )
• Willingness to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site
• Able to provide informed consent
• Adult participants (no age restriction)
• Planned medically indicated kidney biopsy, prescribed by a practicing nephrologist
• ESRD, defined as chronic dialysis or kidney transplant
• History of receiving dialysis for more than 30 days
• Solid organ or bone marrow transplant recipient at time of first kidney biopsy
• Less than 3-year life expectancy
• Known alcohol or substance abuse
• Unable to provide informed consent
• No evidence of active cancer other than non-melanoma skin cancer
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients with C3 Glomerulopathy
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two for…
C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken before and during treatment.
1. Biopsy-proven C3G, either DDD or C3GN, with or without a renal transplant, within 12 weeks prior to screening or during screening:
2. Male or female subjects, aged at least 18 years
3. Female subjects of childbearing potential may participate if adequate contraception is used during, and for at least the three months after study completion; Male subjects with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during, and for at least the 3 months after study completion;
4. Willing and able to give written Informed Consent and to comply with the requirements of the study protocol
5. Judged to be otherwise fit for the study by the Investigator, based on medical history, physical examination, and clinical laboratory assessments.
1. Pregnant or nursing;
2. Secondary C3 disease
3. History or presence of any form of cancer within the 5 years prior to screening,
4. Currently on dialysis or will require dialysis wtihin 7 days of screening
5. Positive hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) viral screening test indicative of acute or chronic infection;
6. Evidence of tuberculosis
7. Evidence of liver disease
A Randomized, Multicenter, Double-Blind, Parallel, Active-Control Study of the Effects of Sparsentan, A Dual Endothelin Receptor and Angiotensin Receptor Blocker, on Renal Outcomes in Patients with Primary Focal Segmental Glomerulosclerosis
This is a randomized, multicenter, double-blind, parallel, a…
This is a randomized, multicenter, double-blind, parallel, active-control study. The investigational drug (sparsentan) is a dual acting angiotensin receptor blocker and endothelin receptor agonist. The active control is irbesartan. Patients who meet eligibility criteria will require wash out from renin-angiotensin-aldosterone system (RAAS) blockers, if applicable prior to their first dose of study drug. Patients will be randomly assigned in a 1:1 ratio to receive either sparsentan or active control (irbesartan).
1. Primary FSGS
2. Male or Female aged 18-75 years
3. Urine protein/creatinine ratio ≥ 1.5 g/g
4. Estimated glomerular filtration rate (eGFR) ≥ 30
5. Blood pressure criteria: ≥100/60 mmHg and ≤160/100 mmHg
6. Women of child bearing potential must agree to the simulataneous use of 2 medically accepted methods of contraception from randomization until 90 days after the last dose of study medication. Males, unless surgically sterile, must agree to use highly reliable methods of contraception from randomization until 90 days after the last dose of study medication.
1. Secondary FSGS
2. History of type 1 diabetes, uncontrolled type 2 diabetes, organ transplantation, heart failure (Class II-IV), malignancy, significant valvular disease, or alcohol/substance abuse.
3. History of significant cerebrovascular disease and/or coronary artery disease within 6 months
4. Body Mass Index (BMI) > 40
3. Females who are pregnant, plan to become pregnant through the course of the study, or are breastfeeding. Males who plan to father a child during the course of the study.
Protocol Dialysis Outcomes and Practice Patterns Study 2
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning…
The Peritoneal Dialysis Outcomes and Practice Patterns Study 2 (PDOPPS 2) is a sociobehavioral research study seeking to identify and analyze the links between modifiable dialysis practices and health outcomes in patients receiving (or planning to receive) chronic Peritoneal Dialysis (PD). The overarching goal of the study is to extend patient survival and improving quality of life for PD patients. There is no intervention being utilized as part of this research, participants will not incur charges as a result of study participation, and participants will not receive any financial compensation for participation in the study. Study participation consists of completing a patient questionnaire that asks about how kidney disease affects well-being and overall quality of life and extraction of data , by the study team, from a participant's medical record to complete other questionnaires associated with overall health. The duration of study participation is approximately 3 years and includes 4 study visits. The study visits consist of completing the an optional patient questionnaire on a yearly basis. The questionnaire will be completed when participants are seen in the dialysis clinic. Individuals can still choose to participate without having to complete the patient questionnaire.
• 18 years of age or older
• Treated at a Peritoneal Dialysis facility
• Receiving chronic, maintenance Peritoneal Dialysis provided by the facility but independent of the facility (for example., at home or a nursing home facility)
• Incident patients must have initiated Peritoneal Dialysis within 60 days of the first Peritoneal Dialysis treatment at home/nursing home
• Less than 18 years of age
• Receiving Peritoneal Dialysis for acute renal failure
• Receiving concomitant Peritoneal Dialysis and Hemodialysis (hybrid therapy) *
• Adults unable to consent/Cognitively impaired
• Pregnant women
• Prisoners or other detained individuals
* Hybrid therapy will be excluded from sampling for incident patients only but will be included in prevalent patient sampling
EMPA-KIDNEY Trial - A multicentre international randomized parallel group double-blind placebocontrolled clinical trial of EMPAgliflozin once daily to assess cardio-renal outcomes in patients with chronic KIDNEY disease
EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardio…
EMPA-KIDNEY is a clinical trial evaluating the effects of empagliflozin on cardiovascular health and progression of chronic kidney disease. This research is studying patients with chronic kidney disease (both with and without diabetes). The study involves taking the study medication every day for about 3-4 years. Additionally, the study team will ask participants to come for study visits, with 3 visits in the first 6 months and then one visit every 6 months until the end of the study. Visits will include surveys, blood and urine collection, and distribution of study medication.
Age is ≥ 18 years at Screening;
There is evidence of chronic kidney disease at risk of kidney disease progression;
A local Investigator judges that the participant neither requires empagliflozin (or any other SGLT-2 or SGLT -1/2 inhibitor), nor that such treatment is inappropriate;
none of the exclusion criteria apply
A Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nefecon in Patients with Primary IgA Nephropathy At Risk Of Progressing to End-Stage Renal Disease (NefIgArd)
The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate …
The overall aim of this phase III, randomized, double-blind,placebo-controlled study is to evaluate the efficacy, safety, and tolerabilityof Nefecon 16 mg per day in the treatment of patients with primaryImmunoglobulin A nephropathy at risk of progressing to end-stage renal diseasedespite maximum tolerated treatment with renin-angiotensin system blockadeusing angiotensin converting enzyme inhibitors or angiotensin II type Ireceptor blockers. The study will consist of 2 parts. Part A will includea 9 month blinded Treatment Period, and a 3-month Follow up Period. Part B willconsist of an observational Long-term Follow up Period in which the patientswill be followed until 100 clinical events, measured as reduction in eGFRcompared to baseline.
A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 with Background Treatment in Subjects with Lupus Nephritis
The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate t…
The "Paisley" study for Lupus Nephritis is a research study that is evaluating an oral investigational drug for people with moderate to severe lupus nephritis.
Other protocol defined inclusion/exclusion criteria could apply
Immune checkpoint inhibitor-associated acute kidney injury
Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer. These medications have been demonstrated to have great promise for trea…
Since 2011, six immune checkpoint inhibitors (ICIs), a type of immunotherapy, have been approved by the Federal Drug Administration for use in patients with cancer. These medications have been demonstrated to have great promise for treating a variety of cancers. However, there are toxicities associated with these agents, known as immune-related adverse events (AKI), some of which can be fatal. Affected organs include the skin (rash), gastrointestinal tract(diarrhea), and the kidneys (acute kidney injury [AKI]). This study, led by Drs. Shruti Gupta and David Leaf at Brigham and Women’s Hospital, has the goal of collecting data on over 300 ICI-associated acute kidney injury cases from more than 30 academic medical centers worldwide. We will characterize the clinical features of ICI-associated AKI in the hope that this will help us to determine predictors of toxicity and best practices for management.