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NCT06836206RecruitingPhase 1/2

The Effect of Gum Arabic (GA) on Residual Renal Function in Adult Dialysis Patients in Abu Dhabi

The Effect of Gum Arabic (GA) on Adult Dialysis Patients in Abu Dhabi: A Prospective Randomized-controlled Trial (The GADAD Study)

Source: ClinicalTrials.gov · Last updated 20 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Gum Arabic (GA), derived from Acacia trees, has shown potential benefits in metabolic, renal, and inflammatory conditions. This study explores the impact of GA on residual renal function in end-stage renal disease (ESRD) patients undergoing dialysis, as current evidence is limited.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
30 Jan 2025
Start date
3 Feb 2025
Primary completion date
30 Nov 2025
Lead sponsor
Abu Dhabi Health Services Company
NCT number
NCT06836206

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 40
  • From 3 Feb 2025 to the primary completion date, 30 Nov 2025
  • 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, not your situation.

Who cannot take part

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

Prior treatment

  • Kidney transplant or booked for a live transplant within 259 days of randomization.
  • Patients on immunosuppression for kidney transplant.
    • Additional exclusion criteria for follow-up visits.

Other illness

  • People with known allergies to quillaja bark or similar tree bark.
  • Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).

Lab values

  • Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.

Other

  • Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
  • Women Pregnant or lactating
  • Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
  • Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
  • Peritoneal dialysis.
  • Patients gaining \>4 kg between dialysis sessions in the past 2 weeks.
  • Patient informs of pregnancy.
  • Severe adverse reaction to the interventional product.

Who the study is looking for

  • To be eligible to participate in this trial, an individual must meet all the following criteria:
  • Men and women ≥18 years of age with diagnosed ESRD and prescribed regular dialysis at least once a week, weekly at least for past two weeks.
  • For past two weeks including women of childbearing potential who are currently adopting any method of contraception or have completed the family and undergone sterilization procedures and women of non-childbearing potential.
  • Patients with residual renal function - Patients who produce a minimum of 200 ml of urine during a full day of collection (A full day collection: the patient discards the first urine sample on the day of collection then collects all urine for the entire day and night and collects the first urine sample of the next day) r on a non-dialysis long break day.
  • Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
  • With the ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
SEHA Kidney Care (SKC)
Coordinator of this site? Confirm its status
Abu DhabiUnited Arab EmiratesRecruiting

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