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Renal Insufficiency, Chronic clinical trials

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NCT ID: NCT03078101 Completed - Clinical trials for Diabetes Mellitus, Type 2

EMPRA (EMPagliflozin and RAs in Kidney Disease)

EMPRA
Start date: April 15, 2017
Phase: Phase 2
Study type: Interventional

This study will be a prospective, clinical pilot study in CKD patients to show whether Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone. Null and alternative hypotheses: H0: Empagliflozin in addition to ACEi treatment does not increase Ang 1-7 levels more than ACEi treatment alone. H1: Empagliflozin in addition to ACEi treatment significantly increases Ang 1-7 levels compared to ACEi treatment alone Methodology: Two groups of 24 chronic kidney disease (CKD) patients, respectively, with and without type 2 diabetes will be randomized into the study medication or placebo group. The number of patients per treatment arms is n = 12. Included and consented patients will be subjected to an initial 2-week run-in period for conversion of current RAS blocking medications to ACEi therapy with enalapril or ramipril and respective dose titration to 10 mg enalapril 2 x daily and 10 mg ramipril 1 x daily. Additional antihypertensive medication will be standardized as feasible, with the primary goal of keeping blood pressure as recommended by KDIGO. Following the 2-week run-in phase, all study patients will be subjected to blood collection including the first RAS quantification (RAS Fingerprint) and assessment of HDL composition, as well as urinary analysis and bioimpedance fluid status assessment (BCM measurement). Subsequently, patients will be randomized to either receive empagliflozin (at a dose of 10 mg daily) or placebo. Subsequently, biweekly study visits including electrolyte and glucose (plasma and urine) monitoring as well as BCM measurement will take place. After 12 weeks of study medication intake, a concluding study visit will be scheduled for final RAS quantification (RAS Fingerprint) and HDL analyses as well as final blood and urinary analysis and BCM measurement. Initially, blood and urine will be collected at the clinical visit as part of the routine blood obtainment (no additional effort on patients). From these routine measurements we will be able to extract information regarding the patient's current CKD stage as well as other relevant laboratory parameters (e.g. HbA1c, UACR, etc.). Furthermore, we will document the patient's current medication and significant comorbidities. Primary analysis variable/endpoint: The difference of Ang 1-7 increase from baseline between a 3-month treatment with empagliflozin on top of ACEi treatment compared to ACEi treatment alone Most important secondary analysis variables/endpoints: 1. Simultaneous quantitative changes of multiple RAS effector angiotensin levels determined by mass-spectrometry 2. Recurrence of Ang II levels determined by mass-spectrometry 3. HDL parameters (protein composition of HDL) 4. Renal parameters (albuminuria reduction measured by urinary albumin-creatinine ratio (UACR), renal function (estimated glomerular filtration rate (GFR), serum-creatinine) 5. Urinary electrolyte levels 6. Urinary glucose levels 7. Urinary RAS metabolites (angiotensinogen, ACE and ACE2 levels, ACE2 activity) 8. Blood pressure determined by ambulatory blood pressure measurements 9. Body volume determined by bioimpedance fluid status assessment (BCM measurement) 10. OCR and ECAR in PBMCs determined by Seahorse Flux Analyzer 11. Assessment of reduction of salt sensitivity by using salt sensitivity test with empagliflozin

NCT ID: NCT03077386 Completed - Hypertension Clinical Trials

Enhancing Community Health Through Patient Navigation, Advocacy and Social Support

ENCOMPASS
Start date: June 8, 2018
Phase: N/A
Study type: Interventional

Some patients who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health navigators (CHNs) who have close community ties, these programs have the potential to reduce barriers to care and increase access to coordinated, person-centred care. The ENCOMPASS program aims to improve the care and health outcomes for high-risk patients by linking patients with chronic disease with a CHN to help them navigate the health system, facilitate communication between patients and providers, improve patients' understanding of their conditions and treatment plans, and support patients in their self-management. In Canada, patient navigation programs have not been well studied or broadly implemented in patients with chronic disease, making a comprehensive evaluation of ENCOMPASS important. This program has great potential to improve care for patients with chronic diseases in primary care.

NCT ID: NCT03077048 Completed - Clinical trials for Renal Insufficiency, Chronic

Short-term Metabolic Effects of Ketosteril® Supplemented Low Protein Diet in Pre-dialysis Chronic Kidney Disease (CKD) Patients

CKD
Start date: March 30, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Supplementation of ketoanalogues of essential amino acids improves the protein quality of protein restricted diets without burdening the kidneys. The ketoanalogues are transaminated by aminotransferases to the corresponding amino acids by incorporating nitrogen from amino groups derived from endogenous amino acid degradation. Therefore, less nitrogen needs to be excreted and the kidney's workload is reduced. The purpose of the trial is to investigate the impact of Ketosteril® supplementation on A) nutritional safety and tolerance of a low protein diet (LPD) (0.6 g protein/kg bodyweight (BW)/day)and B) net protein synthesis in pre-dialysis CKD patients. Changes of urea in serum and urine will be assessed under controlled metabolic balance conditions in non-dialysed CKD patients consuming a LPD supplemented with Ketosteril® at 1 tablet/5 kg body weight/day compared to the same, isonitrogenous and isocaloric diet without Ketosteril®. Changes in protein synthesis and degradation at the defined protein intake with or without Ketosteril® supplementation will be investigated - based on nitrogen balance, normalized protein catabolic rates as well as blood levels of defined proteins as surrogate markers for net protein synthesis and anabolic signaling.

NCT ID: NCT03074188 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Prevalence of Oral Findings in Chronic Kidney Disease

Start date: n/a
Phase: N/A
Study type: Observational [Patient Registry]

There are severe deficiency of database concerning the oral health status in both pre-dialysis and end stage renal disease in Egyptian population. Our aim in the present study is to assess the oral health of the chronic kidney disease patients to increase their awareness and minimize all the possible risk factors, to achieve a proper management for all oral problems.

NCT ID: NCT03073369 Withdrawn - Anemia Clinical Trials

Effect of Ergocalciferol on Iron Metabolism in Individuals With Chronic Kidney Disease

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

The purpose of the study is to learn more about how treatment with vitamin D can affect iron metabolism and blood levels of hepcidin (hormone controlling iron levels) in people with chronic kidney disease (CKD). Iron is an essential mineral which is a major component of proteins that carry oxygen in the blood. Problems with iron metabolism can lead to low blood levels (anemia), which can commonly happen in people with CKD. New research over the last decade has uncovered a new hormone called `hepcidin', which is made in the liver and released into the blood. Hepcidin controls how much iron is in the blood by preventing the absorption of iron from food. Blood levels of hepcidin C are found to be high in people with CKD, and a recent small study in people with normal kidney function showed that treatment with vitamin D decreased hepcidin levels. In this study, investigators would like to examine the effects of vitamin D (Ergocalciferol) on iron metabolism and blood levels of hepcidin in individuals with CKD.

NCT ID: NCT03071263 Completed - Hyperkalemia Clinical Trials

Spironolactone With Patiromer in the Treatment of Resistant Hypertension in Chronic Kidney Disease

AMBER
Start date: January 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if patiromer treatment in chronic kidney disease (CKD) subjects receiving spironolactone for the treatment of resistant hypertension will result in more persistent use of spironolactone through prevention of hyperkalemia and lead to improved blood pressure control compared with treatment with spironolactone alone (placebo).

NCT ID: NCT03067779 Completed - Clinical trials for Chronic Kidney Disease

Is There a Digital Divide in Chronic Kidney Disease (CKD)?

eCRIC
Start date: June 26, 2017
Phase: N/A
Study type: Interventional

This study is looking to improve the safety of patients with chronic kidney disease via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.

NCT ID: NCT03065972 Recruiting - Clinical trials for Chronic Kidney Disease

Hemodialysis in the Elderly (70yrs & Older)

ELDERLY
Start date: January 28, 2016
Phase: N/A
Study type: Interventional

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

NCT ID: NCT03065361 Completed - Clinical trials for Chronic Kidney Disease

Assessing Manual Components of Brazilian Children and Adolescents on Hemodialysis

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study was to assess the handgrip strength; fine motor skills; and hand sensitivity of Brazilian children and adolescents with Chronic Kidney Diseases (CKD). The sample was composed by 42 children and adolescents, 21 on hemodialysis (group A) and the other 21 acted as the control group (group B). The performance of both groups was compared. The outcome measures included Jebsen-Taylor Hand Function Test, the Semmes Weinstein monofilaments test and Jamar Dynamometer.

NCT ID: NCT03063190 Withdrawn - Clinical trials for Vitamin D Deficiency

Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease

RLS
Start date: March 31, 2022
Phase: Phase 4
Study type: Interventional

Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in the general population, being twice as frequent in women and with a tendency to increase incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies on the role of vitamin D supplementation in CKD population are missing. The clinical-scientific hypothesis of this study is that replacement of vitamin D (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.