Rapid Treatment Approach for Chronic Kidney Disease

(RAPID-CKD Trial)

SK
Overseen ByShahzeb Khan, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a rapid treatment approach for individuals with type 2 diabetes and chronic kidney disease. The goal is to determine if quickly starting four kidney medicines—Capoten, Enalapril, Lotensin, and Monopril (types of blood pressure medications)—is safe and effective in improving kidney health compared to standard care, which introduces medicines one at a time. Researchers aim to find out if this approach can reduce kidney damage and maintain kidney function without causing high potassium levels. Participants should have type 2 diabetes, chronic kidney disease, and currently take no more than two kidney-related medications. As a Phase 4 trial, this research involves FDA-approved treatments and seeks to understand how they can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants can be on up to two guideline-recommended drug classes before starting the trial. It's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Studies have shown that starting multiple kidney medications together can be safe for people with chronic kidney disease. These medications, such as Capoten, Enalapril, Lotensin, and Monopril, often manage blood pressure and protect kidney health. Research indicates that while these medicines are generally well-tolerated, they can sometimes affect kidney function or cause high potassium levels.

A review of studies found that ACE inhibitors, like those in this trial, consistently lower the risk of kidney failure and death. Monitoring blood pressure and kidney function is important when using these drugs.

Most patients in other studies handled these medications well, though some experienced mild side effects. The use of these medications is common and approved for many conditions, demonstrating their general safety. Always consult a healthcare provider about potential risks and benefits.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Rapid Treatment Approach for Chronic Kidney Disease because it combines four existing medications—Capoten, Enalapril, Lotensin, and Monopril—into a simultaneous therapy. Unlike the standard of care, which typically involves sequential or individual drug administration, this approach is unique in its potential to provide a more comprehensive and faster-acting treatment. The hope is that by using these medications together, it will enhance their effectiveness and improve patient outcomes more rapidly than traditional methods. This innovative strategy could lead to quicker stabilization of kidney function and better overall management of the condition.

What evidence suggests that this trial's treatments could be effective for chronic kidney disease?

Research has shown that a combination of Capoten, Enalapril, Lotensin, and Monopril can effectively manage chronic kidney disease (CKD) and related heart issues. In this trial, participants in the interventional group will receive all four medications simultaneously. Specifically, studies have found that enalapril significantly reduces hospital visits for heart problems in people with CKD. ACE inhibitors, like those in this treatment, consistently lead to better kidney health compared to other treatments. This combination of medicines helps lower blood pressure, which is crucial for slowing kidney damage. Overall, strong evidence supports this quick treatment approach as beneficial for people with CKD and type 2 diabetes.34678

Are You a Good Fit for This Trial?

This trial is for adults aged 18-84 with type 2 diabetes and chronic kidney disease, who have high protein in their urine and moderately reduced kidney function. Participants must not have other major kidney diseases, severe liver problems, recent serious low blood sugar episodes, or allergies to the study drugs.

Inclusion Criteria

UACR >200 mg/g
I am between 18 and 84 years old.
Systolic BP (SBP) >90 mmHg
See 5 more

Exclusion Criteria

Type 1 diabetes
Life expectancy <6 months
ns-MRA: hyperkalemia
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to four approved kidney medicines over approximately 8 weeks in a rapid treatment approach

8 weeks
Regular clinic visits and lab tests

Follow-up

Participants are monitored for safety and effectiveness after treatment, including kidney function and potassium levels

6 months
Regular clinic visits and laboratory testing

What Are the Treatments Tested in This Trial?

Interventions

  • Capoten
  • Enalapril
  • Lotensin
  • Monopril

Trial Overview

The study compares starting four approved kidney-protecting medicines quickly (over about 8 weeks) versus the usual approach of adding them one at a time over several months. Participants are randomly assigned to either group and followed for about six months.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Control GroupActive Control25 Interventions
Group II: Interventional GroupActive Control25 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Citations

Effects of enalapril in systolic heart failure patients with ... - PMC

Enalapril reduced cardiovascular hospitalization in those with CKD (HR, 0.77; 95% CI, 0.66–0.90; p<0.001) and without CKD (HR, 0.80; 95% CI, 0.70–0.91; p<0.001) ...

A nationwide cohort study comparing the effectiveness of ...

Compared with patients initiating a calcium channel blocker, those initiating a diuretic had a significantly lower risk of chronic kidney ...

Renin-Angiotensin System Inhibitors in Patients With ...

In summary, in our study of patients with nonproteinuric CKD found that use of RASIs was not associated with better kidney outcomes than use of other ...

Clinical outcomes of renin angiotensin system inhibitor-based ...

Most significant reductions in systolic (SBP) and diastolic blood pressure (DBP) were observed with ARB-based CCB dual regimen over ACEI ...

A Bayesian Network Meta-analysis of Randomized Clinical ...

Compared with ARBs, ACE inhibitors were consistently associated with higher probabilities of reducing kidney failure, cardiovascular death, or all-cause death.

Comparative Efficacy and Safety of Angiotensin-Converting ...

This systematic review evaluates the comparative efficacy and safety of antihypertensive therapies, including angiotensin-converting enzyme inhibitors (ACEis), ...

Higher Risk of Kidney Failure Associated With Angiotensin ...

When accounted for the competing risk of death, patients in the ARB group had a 20% (95% CI, 13-28%) higher risk of kidney failure, which was similar in low- ...

New class of antihypertensive medications may have both ...

Chronic kidney disease and high blood pressure are closely linked and, when not managed appropriately, can lead to serious outcomes such as ...