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AzTrials

Diabetic Nephropathy Type 2Phase 2NCT04143412

Efficacy of ACE Inhibitors, MRAs and ACE Inhibitor/ MRA Combination

A Phase 2 study testing Tritace (Ramipril 10 mg) in people with Diabetic Nephropathy Type 2 and Microalbuminuria Due to Type 2 Diabetes Mellitus, run by Beni-Suef University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of our work is to compare the antiproteinuric efficacy of ACEI monotherapy, Selective MRA monotherapy and their combination in mildly hypertensive patients with type 2 diabetes mellitus and microalbuminuria Read more about this study

Who is it for?
Ages 30 to 80 years
What is being tested?
Tritace (Ramipril 10 mg)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteEgypt
Study dates
4 Feb 2019to Mar 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult male and non-pregnant female patients with established diagnosis of type 2 DM at least five years ago with glycosylated hemoglobin (HbA1c) ≤ 8.5%
  • Age 30-80 Y
  • Stage 1 hypertension (systolic BP 140-159 mmHg and/or diastolic BP 90-99 mmHg) and microalbuminuria diagnosed by measuring Urinary albumin/creatinine ratio (UACR) . Microalbuminuria was defined at a level between (30-300 mg/g)
  • Patients included in our study had never been treated with ACEIs, ARBs or aldosterone antagonists, serum potassium level ≥ 3.5 and ≤ 5.0 mmol/L before randomization with estimated glomerular filtration rate (e GFR) ≥50 mL/min/1.73 m2

Who cannot join

  • Patients with type 1 diabetes mellitus
  • Patients with BP ≥ 160/100 mmHg
  • Patients with secondary hypertension
  • Non-diabetic nephropathy including (chronic glomerulonephritis, polycystic kidney disease and nephrosclerosis),
  • Confirmed bilateral renal artery stenosis or stenosis of the renal artery in solitary functioning kidney
  • History of New York Heart Association functional class III and IV heart failure
  • Patients with rapid progression of kidney disease and women who were pregnant, breast-feeding, or planning to become pregnant during the study period

Trial locations and contacts

1 site in 1 country.

Mostafa O El Mokadem, M.D. contact

+201009414408

mostafa.elmokadem9@med.bsu.edu.eg

Egypt1 site, 1 recruiting

  • Faculty of Medicine,Beni-Suef University

    Banī Suwayf, 62511

    Mostafa O El Mokadem, M.D., +201009414408, mostafa.elmokadem9@med.bsu.edu.eg

    Yasser A Abd el Hady, M.D., +201001775524, Yasser.abdelhady@icloud.com

    Recruiting

Other trials in Egypt

About this study

Official title: Antiproteinuric Efficacy of ACE Inhibitors, Selective MRAs and ACE Inhibitor/Selective MRA Combination Therapy in Diabetic Hypertensives With Microalbuminuria

The aim of our work is to compare the antiproteinuric efficacy of ACEI monotherapy, Selective MRA monotherapy and their combination in mildly hypertensive patients with type 2 diabetes mellitus and microalbuminuria

Read the detailed description

Diabetic nephropathy (DN) is the most common cause renal failure in Western countries, responsible for 45% of patients on renal replacement therapy.Diabetic nephropathy was characterized in the early stage by increased albumin excretion in urine, known as microalbuminuria. (DN) results from interactions between different pathological factors that include hyperglycemia, increased activity of the renin-angiotensin-aldosterone-system (RAAS), uncontrolled high systemic and glomerular pressure . (DN) optimal therapy continues to evolve. The main lines of treatment include strict glycemic and blood pressure (BP) control. The angiotensin converting enzyme (ACE) inhibitors have been known to reduce proteinuria both in normotensive and hypertensive patients with diabetic nephropathy and in hypertensive individuals with end stage renal failure . The mechanism by which ACE inhibitors exert their effect on proteinuria reduction is still unknown. The control of high systemic arterial pressure can be beneficial by reducing the filtration pressure. However, no association has been found between antihypertensive effect and proteinuria reduction in several studies. Microalbuminuria which is an early sign of nephropathy can be decreased also by use of Angiotensin receptor blockers (ARBs) in patients with type 2 diabetes mellitus . Insufficient blockade of aldosterone may lead to inadequate anti-albuminuric effects. Studies show that renin-angiotensin-aldosterone system inhibition with ACEI/ARB alone sometimes does not achieve optimal renoprotective effects and does not reduce progression of renal disease, despite therapy. Addition of mineralocorticoid receptor antagonists (MRAs) to angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker therapy was found to reduce proteinuria in patients diabetic nephropathy and can delay progression of renal dysfunction.

Being tested
Tritace (Ramipril 10 mg)
Keywords
microalbuminuria, Diabetic nephropathy, Hperkalemia, Eplerenone, Ramipril
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tritace (Ramipril 10 mg)Drug

    Also called Eraloner (Eplerenone 50 mg), Tritace/ Eraloner (Ramipril 10 mg/ Eplerenone 50 mg)

    Stratified randomized clinical trial

Study groups in NCT04143412
Study groupRoleWhat they receive
Tritace (Ramipril)Active comparator25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Tritace (Ramipril) 10 mg/ day. Full doses will be reached by forced titration after 4 weeks
Receives: Drug: Tritace (Ramipril 10 mg)
Eraloner (Eplerenone)Active comparator25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Eraloner (Eplerenone) 50 mg/ day. Full doses will be reached by forced titration after 4 weeks
Receives: Drug: Tritace (Ramipril 10 mg)
Tritace/Eraloner (Ramipril/Eplerenone)combination therapyActive comparator25 patients with type 2 diabetes mellitus and mild hypertension will be randomized to Tritace/Eraloner (Ramipril 10 mg / Eplerenone 50 mg ) / day. Full doses will be reached by forced titration after 4 weeks
Receives: Drug: Tritace (Ramipril 10 mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urinary albumin/creatinin ratio (UACR)

    Percentage change in albumin/creatinin ratio compared with the baseline value

    Measured: 24 weeks

Secondary outcomes (3)

  1. Blood pressure

    change in blood pressure level

    Measured: 24 weeks

  2. estimated Glomerular Filtration Rate (e GFR)

    change in estimated Glomerular Filtration Rate (e GFR)

    Measured: 24 weeks

  3. Serum K

    change in serum K level

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start4 Feb 2019
  3. Primary completionFeb 2020 (estimated)
  4. Study completionMar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Three parallel groups of therapy; Ramipril 10 mg monotherapy (25 patients) ,Eplerenone 50 mg monotherapy (25 patients) and combination therapy of Eplernone/Ramipril 50/10 mg (25 patients)
Masking
Single blind
Who is masked
Participant
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143412
Sponsor's protocol ID
RAAS blockers in albuminuria
Status last verified
Jan 2020
First submitted
26 Oct 2019
Last updated
18 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To respect privacy and confidentiality of our patients

Publications

  • Espinel E, Agraz I, Ibernon M, Ramos N, Fort J, Seron D. Renal Biopsy in Type 2 Diabetic Patients. J Clin Med. 2015 May 18;4(5):998-1009. doi: 10.3390/jcm4050998.

    PubMed 26239461

  • Zelmanovitz T, Gerchman F, Balthazar AP, Thomazelli FC, Matos JD, Canani LH. Diabetic nephropathy. Diabetol Metab Syndr. 2009 Sep 21;1(1):10. doi: 10.1186/1758-5996-1-10.

    PubMed 19825147

  • Cao Z, Cooper ME. Pathogenesis of diabetic nephropathy. J Diabetes Investig. 2011 Aug 2;2(4):243-7. doi: 10.1111/j.2040-1124.2011.00131.x.

    PubMed 24843491

  • Satirapoj B, Adler SG. Prevalence and Management of Diabetic Nephropathy in Western Countries. Kidney Dis (Basel). 2015 May;1(1):61-70. doi: 10.1159/000382028. Epub 2015 May 1.

    PubMed 27536666

  • Jalal S, Sofi FA, Abass SM, Alai MS, Bhat MA, Rather HA, Lone NA, Siddiqi MA. Effect of amlodipine and lisinopril on microalbuminuria in patients with essential hypertension: A prospective study. Indian J Nephrol. 2010 Jan;20(1):15-20. doi: 10.4103/0971-4065.62090.

    PubMed 20535265

  • Galle J. Reduction of proteinuria with angiotensin receptor blockers. Nat Clin Pract Cardiovasc Med. 2008 Jul;5 Suppl 1:S36-43. doi: 10.1038/ncpcardio0806.

    PubMed 18580865

  • Cagnoni F, Njwe CA, Zaninelli A, Ricci AR, Daffra D, D'Ospina A, Preti P, Destro M. Blocking the RAAS at different levels: an update on the use of the direct renin inhibitors alone and in combination. Vasc Health Risk Manag. 2010 Aug 9;6:549-59. doi: 10.2147/vhrm.s11816.

    PubMed 20730071

  • Cooper LB, Lippmann SJ, Greiner MA, Sharma A, Kelly JP, Fonarow GC, Yancy CW, Heidenreich PA, Hernandez AF. Use of Mineralocorticoid Receptor Antagonists in Patients With Heart Failure and Comorbid Diabetes Mellitus or Chronic Kidney Disease. J Am Heart Assoc. 2017 Dec 23;6(12):e006540. doi: 10.1161/JAHA.117.006540.

    PubMed 29275368

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tritace (Ramipril 10 mg) in people with Diabetic Nephropathy Type 2 and Microalbuminuria Due to Type 2 Diabetes Mellitus, run by Beni-Suef University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mostafa O El Mokadem, M.D. (+201009414408, mostafa.elmokadem9@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary albumin/creatinin ratio (UACR) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143412, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.

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