CLINICAL TRIAL

Renin-Angiotensin (RAAS) bers (ACE/ARB) alone for Type 2 Diabetic Nephropathy

Recruiting · 65+ · All Sexes · Lawrenceville, GA

Safety and Efficacy of Two Year of RAAS Alone or in Combination With Spironolactone Therapy

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About the trial for Type 2 Diabetic Nephropathy

Eligible Conditions
Type 2 Diabetic Nephropathy · Kidney Diseases · Renal Insufficiency, Chronic · Diabetic Nephropathies · Renal Insufficiency

Treatment Groups

This trial involves 3 different treatments. Renin-Angiotensin (RAAS) Bers (ACE/ARB) Alone is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Experimental Group 1
Renin-Angiotensin (RAAS) bers (ACE/ARB) alone
DRUG
+
Renin-Angiotensin (RAAS) blockers in combination with Spironolactone
DRUG
Control Group 2
Renin-Angiotensin (RAAS) blockers in combination with Spironolactone
DRUG
Control Group 3
Renin-Angiotensin (RAAS) alone
DRUG

Eligibility

This trial is for patients born any sex aged 65 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or Female
All eligible patients will be on a stable, maximum to dose of an ACE or ARB for 2 weeks prior to randomization.
Antihypertensiv therapy may be adjusted to achieve the target blood pressure prior to the time of randomization.
ACE or ARB therapy will be the primary antihypertensive therapy used for blood pressure control and will be titrthe highest tolerated dose to achieve a target blood pressure of <Patients requiring additional medications to achieve the target blood pressure will use antihypertensive agents that have neutral effects on urinary proteinuria (e.g. Hydralazine or lo Dihydropyridine calcium channel blockers etc.). CcThe final choice of additional medications will be left to the discretion of the site principal investigator (PI)
Patients with anurine protein to creatinine (UP/Cr) ratio that is mg/gm from the average of two historical value within one year prior to randomization will be considered eligible for study entry.
You are a female above the age of 18. show original
You are receiving oral agents or insulin injections at the time of randomization. show original
The determination of m tolerated ACE-ARB therapy will be left to the discretion of the site physician. show original
Patients with hypertension and target blood pressure of < 140/90mm Hg are eligible for the study. show original
Patients with a baseline K+ of >5.0 meq/L on maximum tolerated ACE-ARB therapy during the screening period can be treated with 8.4 grams of Patiromer for 7 days show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months, 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months, 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months, 24 months.
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Measurement Requirements

This trial is evaluating whether Renin-Angiotensin (RAAS) bers (ACE/ARB) alone will improve 1 primary outcome and 2 secondary outcomes in patients with Type 2 Diabetic Nephropathy. Measurement will happen over the course of 24 months.

Combination Therapy - RAAS inhibition and Spironolactone
24 MONTHS
To determine whether combination therapy with maximally tolerated RAAS inhibition and Spironolactone is superior to RAAS inhibition alone in slowing the progression of renal disease as evidenced by changes in GFR
24 MONTHS
Combination Therapy - RAAS inhibition and Spironolactone to lower UP/Cr
24 MONTHS
To determine whether combination therapy with maximall RAAS inhibition and Spironolactone is superior to RAAS inhibition alone in lowering the UP/Cr ratio at 12 months
24 MONTHS
Combination Therapy - RAAS inhibition and Spironolactone that develop hyperkalemia
12 MONTHS, 24 MONTHS
To determine the patients in the maximal RAAS blockade group and those receiving combination RAAS + Spironolactone therapy developing clinically significant hyperkalemia as defined as a serum K+ level greater than 5.5 meq/L. We will determine the percentage of patients that require "Patiromer-Rescue" for K+ > 5.5 meq/L and the percentage of patients maintained with serum K+ less than 5.5 meq/L
12 MONTHS, 24 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes type 2 diabetic nephropathy?

This case highlights the need for a full, detailed history and thorough physical work-up to rule out other causes of nephropathy. The lack of association between eGFR and urinary albumin excretion suggests that nephropathy is likely to occur without a significant fall in renal function.

Anonymous Patient Answer

What are common treatments for type 2 diabetic nephropathy?

The majority of patients with type 2 diabetic nephropathy underwent renal replacement therapy and/or intervention. Statins were the most common therapy. These data add valuable insight to treatment of type 2 diabetes in the CKD population.

Anonymous Patient Answer

What is type 2 diabetic nephropathy?

The disease evolves over time through various steps (albuminuria, microalbuminuria, macroalbuminuria, and CKD stage 3 and 4) which lead to the need for dialysis and its complications.

Anonymous Patient Answer

How many people get type 2 diabetic nephropathy a year in the United States?

Because these data do not differ substantially from national data from the previous year, and no significant trends appear to be apparent for either prevalence or incidence over the last decade, national estimates of the prevalence of type 2 diabetic nephropathy in adults are likely to be valid.

Anonymous Patient Answer

What are the signs of type 2 diabetic nephropathy?

It is difficult to identify signs of kidney damage until proteinuria or microalbuminuria become apparent. Most people with diabetes who develop significant proteinuria do not have a history of kidney disease. The use of eGFR in the surveillance of proteinuria is warranted.

Anonymous Patient Answer

Can type 2 diabetic nephropathy be cured?

The type 2 diabetic patient's proteinuria can be controlled in about half of patients, even with intensive conventional therapy with drugs like ACE inhibitor or angiotensin-receptor antagonist.

Anonymous Patient Answer

Have there been any new discoveries for treating type 2 diabetic nephropathy?

The discovery to date has included only one drug, which has been approved from the European Union. More effective drugs are necessary for treatment of diabetic kidney disease.

Anonymous Patient Answer

What is the average age someone gets type 2 diabetic nephropathy?

Based on data from 8 large type 2 diabetic populations and adjusting for gender, race, and age, the most recently reported average age of diabetic nephropathy onset at diagnosis was 61.3 years, with black individuals diagnosed earlier than other ethnic or racial groups. We propose that further validation be done around this current cutoff, as earlier diagnoses could have a major impact on healthcare utilization for persons with type 2 diabetes and diabetic-end-stage kidney disease.

Anonymous Patient Answer

Is renin-angiotensin (raas) bers (ace/arb) alone typically used in combination with any other treatments?

Data from a recent study indicates that while RAS bers may be used alone in most cases and may be effective in controlling the course of CKD, its effectiveness is significantly higher when combined with other treatments.

Anonymous Patient Answer

What are the common side effects of renin-angiotensin (raas) bers (ace/arb) alone?

There was no apparent difference in the rate of side effects between the RASBs or placebo; however, side effects were significantly more common in men. The most common side effect in patients receiving ACE inhibitor monotherapy, as compared to patients who received only ARB, was dizziness.

Anonymous Patient Answer

Does type 2 diabetic nephropathy run in families?

The prevalence of [type 2 diabetes](https://www.withpower.com/clinical-trials/type-2-diabetes) mellitus was 4.4 times higher among diabetic patients than in the general Norwegian population. The mean age of diagnosis of type 2 diabetes was 59.9 (19.8) years, which is considerably higher than the mean age of diagnosis of diabetes (23.6 (8.4)) in the general Norwegian population. A major (p=0.027) difference in the prevalence of the HbA(1c) values was found between the group who has been diagnosed with type 2 diabetes and the control group; the mean of HbA(1c) was 7.0% (1.2%) in the group with type 2 diabetes as compared with 5.9% (1.

Anonymous Patient Answer

Have there been other clinical trials involving renin-angiotensin (raas) bers (ace/arb) alone?

The combination of ACE inhibitor and ARB may yield more effective antiproteinuria and less deterioration of renal function than treatment with either ACE inhibitors or ARBs alone.

Anonymous Patient Answer
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