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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months, 24 months
Awards & highlights
MRA-ACE Trial 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.Check my eligibility
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.See study design
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.
MRA-ACE Trial 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.
MRA-ACE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Combination Therapy - RAAS inhibition and Spironolactone to lower UP/Cr
Secondary outcome measures
Combination Therapy - RAAS inhibition and Spironolactone
Combined Modality Therapy
MRA-ACE 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
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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:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical conditions typically respond to a dual therapy of RAAS blockers and Spironolactone?
"Renin-Angiotensin (RAAS) blockers combined with Spironolactone may be employed to ameliorate conditions such as ventricular dysfunction, left and cirrhosis of the liver. Additionally, this combination therapy can prove beneficial in cases where monotherapy fails to treat asymptomatic left ventricular dysfunction."
Answered by AI
How many participants are currently taking part in this clinical investigation?
"Affirmative. Clinicaltrials.gov data indicates that the trial was launched on October 1st 2018 and is still recruiting candidates today, with a total of 72 patients needed across 2 sites."
Answered by AI
Has the FDA approved the use of a combination therapy involving Renin-Angiotensin (RAAS) blockers and Spironolactone?
"The safety of the combination therapy involving Renin-Angiotensin (RAAS) blockers and Spironolactone has been approved by medical authorities, so it is rated a 3 on our scale."
Answered by AI
Is there still capacity for individuals to join the research project?
"Affirmative, research posted on clinicaltrials.gov reveals that this medical study is presently enrolling participants. This experiment was initially published on October 1st 2018 and subsequently updated on October 27th 2022. 72 patients are being recruited from two different sites for the trial."
Answered by AI
What prior research exists on the synergistic effects of RAAS blockers and Spironolactone?
"The first research on the combination of Renin-Angiotensin (RAAS) blockers and Spironolactone emerged from Dept. of Nephrology, Herlev University Hospital in 2005. As of today, there are 601 completed studies regarding this topic; out of which 122 trials remain active with a large concentration located around Bethlehem, Pennsylvania."
Answered by AI
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