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ACE/ARB
RAAS Blockers + Spironolactone for Diabetic Kidney Disease (MRA-ACE Trial)
Phase 4
Recruiting
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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
James A. Tumlin, MDLead Sponsor
Nelson Kopyt, MDUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Type II diabetes and am currently on medication or insulin.My potassium levels are high even though I'm taking 16.8g/day of Patiromer.I have a history of Type I diabetes.I am allergic or intolerant to Spironolactone.I am currently taking digoxin.I am over 18 years old.It seems like the criterion is incomplete. Can you please provide more context or details so that I can accurately summarize it for you?My blood pressure is below 140/90 mm Hg.My blood pressure medication can be changed to meet the trial's requirements.I am taking blood pressure medication that does not affect my kidney protein levels.My potassium level is above 5.5 despite my current heart medication.My kidney function, measured by GFR, is good.I am using birth control.I am either male or female.I am not willing or able to use hormone-based or barrier birth control methods.Your kidney function is very low, with an estimated GFR less than 20 mL/min/1.73 m2.I am taking more than 10mg of Prednisone daily.I have been on a stable, high dose of ACE inhibitors or ARBs for at least 2 weeks.Your urine protein to creatinine ratio is within a certain range.I am currently taking Amiloride, Aliskiren, or similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: RAAS alone
- Group 2: RAAS in Combination with Spironolactone
Awards:
This trial has 5 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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