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NCT05807711CompletedPhase 4

Efficacy of L-methylfolate and Methylcobalamine in Treating Resistant Hypertension Associated With Elevated Serum Homocysteine in Hemodialysis Patients.

Source: ClinicalTrials.gov · Last updated 13 Jan 2025

Brief summary (registry, in English)

The aim of the study is to evaluate the efficacy of L-methylfolate in combination with methylcobalamine in reducing homocysteine blood levels in hypertensive end-stage renal disease patients on regular hemodialysis and its association with blood pressure control in treatment of resistant hypertension

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
51 (actual)
First submitted
29 Mar 2023
Start date
1 Apr 2023
Primary completion date
1 May 2024
Lead sponsor
Alexandria University
NCT number
NCT05807711

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 51
  • From 1 Apr 2023 to the primary completion date, 1 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Medication side effects (methotrexate, theophylline, phenytoin, and cyclosporine) or any drug proven to cause hyperhomocysteinemia

Other illness

  • Severe hepatic impairment
  • Acute kidney injury on top of chronic kidney disease
  • Allergy or intolerance to any component of the formulation

Age

  • Age \> 75 years

Other

  • Excessive use of alcohol or smoking
  • Pregnant females

Who the study is looking for

  • Adult end stage renal disease patients maintained on hemodialysis three times a week for at least 3 months with resistant hypertension as determined by pre-dialysis BP \> 140/90 mm Hg, post-dialysis BP \> 130/80 mm Hg despite the use of three or more drugs

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Faculty of Pharmacy, Alexandria University
Coordinator of this site? Confirm its status
AlexandriaEgyptUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.