RecruitingPhase 1Phase 2NCT06836206

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)

Sponsor

Abu Dhabi Health Services Company

Enrollment

40 participants

Start Date

Feb 3, 2025

Study Type

INTERVENTIONAL

Conditions

End Stage Renal Disease (ESRD)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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.

Exclusion Criteria13

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.
Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
Peritoneal dialysis.
Kidney transplant or booked for a live transplant within 259 days of randomization.
Patients gaining \>4 kg between dialysis sessions in the past 2 weeks.
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).
Patients on immunosuppression for kidney transplant.
Patient informs of pregnancy.
Severe adverse reaction to the interventional product.