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92 active trials for Chronic Kidney Disease

Integrating Risk-based Care for Patients With CKD

Chronic kidney disease (CKD) and its end stage of kidney failure are major public health problems in Canada and worldwide. In the primary care setting, accurate prediction of the risk of kidney failure in patients with CKD can improve patient provider communication, assist in appropriate nephrology referral, improve dialysis treatment planning, and identify patients who are most likely to benefit from intervention. To aid in accurately predicting the risk of kidney failure requiring dialysis in patients with CKD, the primary investigator has developed and validated the kidney failure risk equation (KFRE), which is increasingly used in nephrology practices across Canada and the United States. In this current study, a cluster randomized controlled trial (RCT) will be done in collaboration with the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). Primary care clinics that can integrate the KFRE into their electronic medical records will be randomized to receive the intervention (patients and providers receive individualized information explaining kidney failure risk, as well as risk-based criteria for referral, alongside usual care) versus usual care alone (no information on personalized risk and no risk-based referral). In both groups, the investigators will assess management of patients at high risk of kidney failure (patient), timing of referral for patients at high risk of kidney failure (health system), cost of CKD care (health system), CKD-specific health literacy (patient), trust in physician care (patient), and satisfaction with risk prediction tools (provider). The objective of this research study is to develop, implement, and evaluate tools to guide the care of patients with CKD in the community, including appropriate referral using a risk-based approach. Specifically, this study will address the question: "Does providing patients (and their physicians) with information about their risk of kidney failure improve quality of care, health literacy, and trust in the care they are receiving?"

Start: August 2018

House Calls and Peer Mentorship

Live donor kidney transplantation (LDKT) offers the most optimal survival and quality of life benefit for those with late-stage chronic kidney disease. However, minorities, especially blacks, are much less likely to receive LDKT than whites. Given the shortage of deceased donor organs, interventions expanding access to LDKT are needed, particularly for minority patients. House Calls (HC), an educational intervention developed by this study's PI has been shown to be an effective program for raising rates of live donation, especially for black patients. While the HC program has shown outstanding results, participant feedback suggested that follow-up may provide even more benefits. Previous research suggests that peer mentorship (PM) from former or current patients with ESRD may be effective in raising rates of living donation. As such, peer mentorship programs may act as an effective follow-up for HC participants. This study will examine the impact of the HC intervention combined with the peer mentorship program of the National Kidney Foundation on rates of live donor kidney transplantation.

Start: April 2018

A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Chronic Kidney Disease Who do Not Have Diabetes

This study is open to adults who have kidney disease and do not have diabetes. The purpose of the study is to find out whether a medicine called BI 685509 improves kidney function. Three different doses of BI 685509 are tested in this study. Participants get either one of the three doses of BI 685509 or placebo. It is decided by chance who gets which BI 685509 dose and who gets placebo. Participants take BI 685509 or placebo as tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of BI 685509 and placebo. During the study, the doctors also regularly check the general health of the participants.

Start: April 2021

Study of the Effect of SZC on Serum Potassium and Serum Bicarbonate in Patients With Hyperkalemia and Metabolic Acidosis Associated With Chronic Kidney Disease

The main objective of this study is to evaluate the efficacy of SZC as compared to placebo in maintaining normal sK+ in patients with hyperkalemia and metabolic acidosis associated with CKD

Start: March 2021

A Study on Patients With Chronic Kidney Disease (CKD) to Assess Treatment Experience and Patterns, Effect of the Treatment, Patient Outcomes and Patient Quality of Life

DISCOVER CKD is an international observational cohort study in patients with CKD, comprising both prospective and retrospective patient cohorts. The study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care.

Start: September 2019

A Study to Examine Past Estimated Glomerular Filtration Rate (eGFR) Slope as a Risk Marker for Rapid Kidney Function Decline in People With Chronic Kidney Disease

This study is intended to investigate the usefulness of estimated glomerular filtration rate (eGFR) slopes derived from retrospective routine clinical practice data, compare those retrospective slopes with those generated in a prospective fashion and successively identify rapidly progressing chronic kidney disease (CKD) patients.

Start: June 2021

Proteogenomic Monitoring and Assessment of Liver Transplant Recipients

This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's ability to function properly. Early detection of these conditions could assist with successful treatment and possibly lead to less repeat organ transplants.

Start: April 2010

Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

The purpose of the study is to evaluate the efficacy and safety of AZD9977 alone and AZD9977 in combination with dapagliflozin and to assess the dose-response relationship of placebo, AZD9977 alone, dapagliflozin alone and 3 doses of AZD9977 combined with dapagliflozin on urinary albumin to creatinine ratio (UACR). The study will be conducted in participants with heart failure (HF) with left ventricular ejection fraction (LVEF [below 55%]) and chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR [between 20 and 60 mL/min, with at least 30% of participants with eGFR <30 mL/min and a maximum of 25% of participants with eGFR >45 mL/min]), including at least 40% of participants with type 2 diabetes mellitus (T2DM).

Start: January 2021

Zibotentan and Dapagliflozin for the Treatment of CKD (ZENITH-CKD Trial)

The purpose of the study is to assess efficacy, safety and tolerability of treatment with zibotentan and dapagliflozin in combination and alone, compared with placebo in participants with chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) between 20 and 60 mL/min/1.73^2.

Start: April 2021

Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease

Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to 100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy individuals. The objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current HPV vaccination strategies and to investigate the immune response to different routinely administered HPV vaccines in European paediatric SOT candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.

Start: March 2017

A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol

This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad prolonged release Hydroxypropyl methylcellulose [HPMC] capsule 12 mg) and allopurinol (i.e. allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the relative bioavailability between a formulation only containing verinurad (i.e. verinurad prolonged release gelatin capsule 12 mg) and the FDC capsule.

Start: April 2021

A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease

The purpose of the study is to evaluate the dose-response efficacy, safety, and pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.

Start: October 2020

EMPA-KIDNEY (The Study of Heart and Kidney Protection With Empagliflozin)

The primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease

Start: January 2019

REVEAL-CKD: Prevalence and Consequences of Undiagnosed Chronic Kidney Disease

This is a retrospective, multinational, non-interventional, observational study. A series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 CKD in each region. The study will also assess the current state of CKD management in patients with undiagnosed CKD

Start: December 2020

Effects of Sulforaphane for Patients With Chronic Kidney Disease

Patients with Chronic Kidney Disease (CKD) have many complications associated with inflammation, oxidative stress and intestinal dysbiosis, which are closely related to the progression of kidney failure and cardiovascular disease. Sulforaphane, an isothiocyanate found in cruciferous vegetables (Family: Brassicaceae) is recognized as one of the most important activators of erythroid nuclear factor 2 related to factor 2 (Nrf2). However, clinical evidence to assess the effects of sulforaphane in patients with CKD is scarce, and there are no studies that have investigated its effects on the expression of genes and markers related to inflammation in these patients. Thus, the present project proposes a longitudinal study of the clinical trial type that aims to evaluate the effects of sulforaphane on transcription factors and inflammatory markers in patients with CKD.

Start: September 2021

Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment

Researchers are looking for a better way to treat people with chronic kidney diseases. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the drug in the body. In this study researchers will investigate how the liver function influences blood concentrations of runcaciguat in participants with different degrees of liver impairment compared to participants with normal liver function. The participants will all take one tablet with 15 mg runcaciguat by mouth. Prior to inclusion into the study, all participants will have a screening examination within 21 to 2 days prior to dosing to check eligibility for study participation. During the study, all of the participants will stay at the study site for up to 8 days (from Day -1 to Day 7), whereby Day 6 and 7 might also be performed in an ambulatory setting. Blood and urine samples will be collected. The physician will check the participants' heart health using an electrocardiogram (ECG) and by measuring blood pressure and heart rate. The participants will answer questions about their wellbeing and taken medications. The participants will have a follow-up examination 7 to 11 days after dosing to follow-up their health. Each participant will be in the study for approximately 5 weeks. The entire study will last about 9 months.

Start: April 2021

A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

A PHASE 1, OPEN-LABEL SAFETY, TOLERABILITY, AND EARLY EFFICACY STUDY OF A RENAL AUTOLOGOUS CELL THERAPY (REACT) IN PATIENTS WITH CHRONIC KIDNEY DISEASE FROM CONGENITAL ANOMALIES OF THE KIDNEY AND URINARY TRACT (CAKUT) (REGEN-004)

Start: August 2019

Biomarker for Patients With Fabry Disease (BioFabry)

Development of a new mass spectrography-based biomarker for the early and sensitive diagnosis of Fabry disease from the blood

Start: August 2018

A Study of Verinurad and Allopurinol in Patients With Chronic Kidney Disease and Hyperuricaemia

The purpose of this clinical research study is to establish the dose of verinurad combined with allopurinol 300 mg once daily that will elicit the desired response; ie, reduction in urinary albumin to creatinine ratio (UACR) at 6 months.

Start: July 2019

Replication of the DAPA-CKD (Chronic Kidney Disease) Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Start: December 2020