Diuretics for Early Chronic Kidney Disease (DOCK Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: VA Office of Research and Development
No Placebo Group
Prior Safety Data
Approved in 5 jurisdictions
Trial Summary
What is the purpose of this trial?This trial is testing whether medications that help remove extra fluid from the body can improve heart health in Veterans with early-stage kidney disease and high blood pressure. By reducing fluid volume, these medications may lower blood pressure and decrease heart strain. These medications have been used to manage extra fluid buildup and control blood pressure in various conditions, including heart failure and high blood pressure, for many years.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of diuretics for early chronic kidney disease?
The research indicates that in chronic kidney disease patients, there was an increase in the prescription of diuretics when patients were followed up in renal protection clinics, suggesting that these drugs are considered beneficial in managing the condition.
12345Are diuretics safe for people with chronic kidney disease?
Diuretics, including thiazide and loop types, have been used for many years and are generally safe, but they can have side effects like low sodium or potassium levels, especially in people with kidney issues. Potassium-sparing diuretics are considered safer in some cases, but all types should be used with caution and under medical supervision, particularly in those with advanced kidney disease.
678910How is the drug Diuretic Augmentation unique for treating early chronic kidney disease?
Diuretic Augmentation, which includes thiazide and loop diuretics, is unique because it combines different types of diuretics to potentially enhance their effectiveness in managing early chronic kidney disease, despite concerns about their efficacy in advanced stages. This combination may offer renoprotective benefits and better blood pressure control, especially in patients with conditions like type 2 diabetic kidney disease.
68111213Eligibility Criteria
This trial is for Veterans with early-stage chronic kidney disease (CKD stages 1-3) who have high blood pressure. Participants must be at least 18 years old, able to give informed consent, and not on dialysis or a recipient of a kidney transplant. Those with severe heart issues, liver cirrhosis, major limb amputation, pregnancy, or certain devices like pacemakers are excluded.Exclusion Criteria
I am able to understand and give informed consent.
My kidney function is very low (stage 4-5 CKD).
I have been diagnosed with liver cirrhosis.
I am willing and able to follow the study's requirements.
I have received a kidney transplant.
I am on long-term dialysis treatment.
I have had a major limb amputation.
Participant Groups
The study tests whether diuretics (like hydrochlorothiazide or furosemide) can reduce fluid overload in the body and improve cardiovascular health in people with early CKD. It compares two methods of measuring fluid overload and observes changes in symptoms and short-term heart function after treatment.
1Treatment groups
Experimental Treatment
Group I: Diuretic augmentationExperimental Treatment1 Intervention
The participant's blood pressure medication regimen will be altered to initiate a thiazide-type or loop diuretic in those not already prescribed a diuretic, or to increase the dose if one is already prescribed.
Diuretic Augmentation is already approved in European Union, United States, Canada, Japan, China for the following indications:
🇪🇺 Approved in European Union as Diuretics for:
- Hypertension
- Edema
- Heart failure
- Chronic kidney disease
🇺🇸 Approved in United States as Diuretics for:
- Hypertension
- Edema
- Heart failure
- Chronic kidney disease
- Nephrotic syndrome
🇨🇦 Approved in Canada as Diuretics for:
- Hypertension
- Edema
- Heart failure
- Chronic kidney disease
🇯🇵 Approved in Japan as Diuretics for:
- Hypertension
- Edema
- Heart failure
🇨🇳 Approved in China as Diuretics for:
- Hypertension
- Edema
- Heart failure
- Chronic kidney disease
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Michael E. DeBakey VA Medical Center, Houston, TXHouston, TX
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
References
The impact of renal protection clinics on prescription of and adherence to cardioprotective drug therapy in chronic kidney disease patients. [2020]Background: The aim of this study was to assess the impact of follow-up in renal protection clinics on the prescription of and adherence to cardioprotective drugs in patients with chronic kidney disease (CKD). Methods: We studied stage 4 and 5 CKD patients who initiated follow-up in three renal protection clinics. The prescription pattern of antihypertensive agents (AHA) and lipid-lowering agents (LLAs) was measured as the percentage of patients who are prescribed the agents of interest at a given time. Adherence to drug therapy was defined as the percentage of days, during a pre-defined observation period, in which patients have an on-hand supply of their prescribed medications. Results: A total of 259 CKD patients were enrolled and followed for up to 1 year after referral to renal protection clinics. There was a significant increase in the prescription of angiotensin-converting enzyme inhibitors (34-39%), angiotensin II receptor blockers (11-14%), beta-blockers (40-51%), calcium channel blockers (62-74%), diuretics (66-78%) and LLAs (39-47%) during follow-up in the renal protection clinic compared with baseline (P-values <0.01 for all comparisons). The proportions of patients with good (≥ 80%) and poor (< 80%) adherence to AHA (P = 0.41) and LLAs (P = 0.11) were similar in the year preceding and the year following the first visit to the renal protection clinics. Conclusion: Our results suggest that referral and follow-up in a renal protection clinic may increase the prescription of cardioprotective agents in CKD patients, but does not appear to improve adherence to these medications.
Understanding barriers to optimal medication management for those requiring long-term dialysis: rationale and design for an observational study, and a quantitative description of study variables and data. [2022]Rates of medication non-adherence in dialysis patients are high, and improving adherence is likely to improve outcomes. Few data are available regarding factors associated with medication adherence in dialysis patients, and these data are needed to inform effective intervention strategies.
The role of clinical pharmacist in enhancing hemodialysis patients' adherence and clinical outcomes: a randomized-controlled study. [2022]Adherence to treatment recommendations is challenging in hemodialysis (HD) patients, yet it has been found to be extremely crucial in obtaining positive clinical and health outcomes.
Undiagnosed kidney disease in hospitalised patients: an opportunity for improvement. [2013]In hospitalised patients, chronic kidney disease (CKD) is associated with a high risk of morbidity, mortality and drug toxicity. We identified care improvement opportunities in hospitalised patients with kidney disease in a regional hospital.
Comparison of the effect of educational and self-management interventions on adherence to treatment in hemodialysis patients: A systematic review and meta-analysis of randomized controlled trials. [2021]Adherence to fluid intake, diet, and drug management is very important in hemodialysis patients. Educational and self-management interventions are frequently used to improve adherence to treatment in hemodialysis patients.
Revisiting diuretic choice in chronic kidney disease. [2023]Existing guidelines offer little direction about the use of thiazide and loop diuretics in patients with chronic kidney disease (CKD). This review summarizes recent studies impacting indications and safety considerations for these agents in patients with CKD.
Hyponatraemia and hypokalaemia due to indapamide. [2020]To review Australian adverse drug reaction reports describing hyponatraemia and hypokalaemia attributed to indapamide and compare the characteristics of the patients with those in Australian reports implicating two other diuretic products (hydrochlorothiazide and amiloride hydrochloride; chlorothiazide).
Thiazides in chronic kidney disease: "back to the future". [2023]The thiazide class diuretics are first-line agents for managing hypertension either as monotherapy or as a fixed-dose combination with other antihypertensive drugs. However, despite the extensive experience with these drugs for >60 years, there is general reluctance to use these agents in patients with advanced chronic kidney disease (CKD) because of concerns about their efficacy and safety as kidney function declines. In this issue of Clinical Kidney Journal, Minutolo et al. performed an updated review of the pharmacological properties, efficacy and side effects and randomized controlled trials that tested these drugs in patients with CKD.
[Potassium-sparing diuretics (spironolactone, triamterene, amylorid)]. [2013]The group of drugs, so-called "potassium sparing diuretics" represent an important part of our modern therapeutic arsenal. Their "weak diuretic" properties are especially beneficial in cirrhotic patients with ascites, when highly effective loop diuretics may be hazardous. Potassium sparing diuretics have not only the advantage of avoiding potassium loss, but can potentiate the effects of diuretics acting in distal tubules and Henle's loop also. They may be combined by each other or ACE inhibitors too, taking the necessary precautions and laboratory monitoring. Their indications include the hypertension and special diseases as Conn's, Bartter's, Liddle syndromes and hirsutism. The broad clinical usefulness justifies the drug inventory ambition to develop new, more effective potassium sparing compounds without side effects. Authors overview their main clinicofarmacological properties, therapeutical indications alone or in combinations and their potential side effects.
The place of loop diuretics in the treatment of acute and chronic renal failure. [2010]Loop diuretics (furosemide, bumetanide, muzolimine, piretamide, torasemide) are powerful drugs capable of increasing sodium excretion and urine output even when renal function is markedly impaired. In patients with chronic renal failure (CRF), loop diuretics may be given to control extracellular volume (ECV) expansion responsible for hypertension. But the use of loop diuretics in chronic uremia is mostly helpful when impaired renal function co-exists with nephrotic syndrome or chronic heart failure. Due to their powerful natriuretic activity, loop diuretics have been administered also to patients on maintenance dialysis to reduce the frequency of and/or to curtail dialysis time. In this condition, however, the increase of sodium and water excretion is very limited; whereas the use of diuretics in high dosage is not devoid of risky side effects such as neurologic lesions, cramps, deafness, weakness, muscle pain. In some patients with oliguric form of acute renal failure (ARF), loop diuretics increase sodium excretion and urine output. They do not affect the mortality rate for ARF but may facilitate the treatment of patients by reverting an oliguric form to a non-oliguric form of ARF.
The Use of Thiazide Diuretics for the Treatment of Hypertension in Patients With Advanced Chronic Kidney Disease. [2023]The use of thiazide diuretics for the treatment of hypertension in patients with advance chronic kidney disease. Thiazides have been recommended as the first-line for the treatment of hypertension, yet their use has been discouraged in advanced chronic kidney disease (CKD), as they are suggested to be ineffective in advanced CKD. Recent data suggest that thiazide diuretics may be beneficial blood pressure control in addition to natriuresis in existing CKD. This review discusses the commercially available thiazides with a focus on thiazide pharmacology, most common adverse effects, clinical uses of thiazide diuretic, and the evidence for efficacy of thiazide use in advanced CKD.
Renoprotective effects of thiazides combined with loop diuretics in patients with type 2 diabetic kidney disease. [2021]Type 2 diabetic kidney disease (DKD) is frequently accompanied by uncontrollable hypertension due to the sodium sensitivity inherent in DKD and to diuretic-resistant edema. In general, diuretics are effective in treating this condition, but thiazide diuretics are thought to be innocuous in advanced chronic kidney disease (CKD). We examined the renoprotective effects of combination therapy with thiazides and loop diuretics in type 2 DKD patients with CKD stage G4 or G5.
Association of Continuation of Loop Diuretics at Hemodialysis Initiation with Clinical Outcomes. [2023]Loop diuretics are commonly used to manage nondialysis-dependent CKD. Despite benefits of augmented urine output, loop diuretics are often discontinued after dialysis initiation. Here, we assessed the association of the early decision to continue loop diuretics at hemodialysis start with clinical outcomes during the first year of dialysis.