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ACE/ARB

RAAS Blockers + Spironolactone for Diabetic Kidney Disease (MRA-ACE Trial)

Phase 4

Waitlist Available

Research Sponsored by James A. Tumlin, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with Type II diabetes mellitus must be receiving oral agents or insulin injections at the time of randomization

Age above 18

Must not have

Patients with serum K+ > 5.00 while taking 16.8g/day of Patiromer

Patients with history of Type I diabetes mellitus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months, 24 months

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial will study whether combining two drugs will reduce urinary protein and slow the decline of kidney function in diabetes patients.

Who is the study for?

Adults with chronic kidney conditions, including those with diabetic kidney disease, who are on stable maximum doses of ACE inhibitors or ARBs and have controlled blood pressure. They must not be pregnant, breastfeeding, or have severe allergies to Spironolactone. Participants need a certain level of kidney function (eGFR >73 m2) and specific urine protein levels.

What is being tested?

The trial is testing if adding Spironolactone to standard Renin-Angiotensin System blockers can better reduce urinary protein over one year and slow down the decline in kidney function over two years. It also examines if Patiromer helps manage high potassium levels from this combination therapy.

What are the potential side effects?

Potential side effects include significant increases in potassium levels which could lead to heart issues. There may also be risks associated with long-term use of RAAS blockers and Spironolactone such as changes in blood pressure, electrolyte imbalances, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Type II diabetes and am currently on medication or insulin.

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I am over 18 years old.

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My blood pressure is below 140/90 mm Hg.

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My kidney function, measured by GFR, is good.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My potassium levels are high even though I'm taking 16.8g/day of Patiromer.

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I have a history of Type I diabetes.

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I am allergic or intolerant to Spironolactone.

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I am currently taking digoxin.

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I am not willing or able to use hormone-based or barrier birth control methods.

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I am taking more than 10mg of Prednisone daily.

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I am currently taking Amiloride, Aliskiren, or similar medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Combination Therapy - RAAS inhibition and Spironolactone to lower UP/Cr

Secondary study objectives

Combination Therapy - RAAS inhibition and Spironolactone

Combined Modality Therapy

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Active Control

Group I: RAAS aloneActive Control1 Intervention

RAAS (Lisinopril, Enalapril, Perindopril, Losartan, and Valsartan taken each day at maximum tolerated dose that will different for each subject)

Group II: RAAS in Combination with SpironolactoneActive Control1 Intervention

RAAS (Lisinopril, Enalapril, Perindopril, Losartan, and Valsartan taken each day at maximum tolerated dose that will different for each subject); Spironolactone taken each day at 25mg

0 / 11Eligibility criteria met