Effect of Gum Arabic on Kidney Function in Dialysis Patients

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

This study is testing if adding Gum Arabic to the treatment of dialysis patients with kidney failure can improve their kidney function and overall health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Abu Dhabi Health Services Company (Government)
• Locations: 1 site (Abu Dhabi)
• Trial ID: NCT06836206 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of Gum Arabic (GA) on residual renal function in adult patients with end-stage renal disease (ESRD) who are undergoing dialysis. Participants will receive GA supplementation alongside their regular treatment to assess its effects on various renal and metabolic parameters. The study aims to gather evidence on the potential benefits of GA, which has been traditionally used for its health properties, particularly in renal health. The trial will involve a comprehensive evaluation over a maximum period of 266 days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with diagnosed ESRD who are currently on regular dialysis and have some residual renal function.

Not a fit: Patients who do not produce any urine or have advanced ESRD with no residual renal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve kidney function and overall health outcomes for dialysis patients.

How similar studies have performed: Previous studies have shown promising results regarding the effects of Gum Arabic on renal health, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

To be eligible to participate in this trial, an individual must meet all the following criteria:

1. 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.
2. 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.
3. 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.
4. Able and willing to complete the whole period of the study (maximum of 266 days from enrolment).
5. 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 Criteria:

1. Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization.
2. Women Pregnant or lactating
3. Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization.
4. Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records.
5. Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment.
6. Peritoneal dialysis.
7. Kidney transplant or booked for a live transplant within 259 days of randomization.
8. Patients gaining \>4 kg between dialysis sessions in the past 2 weeks.
9. People with known allergies to quillaja bark or similar tree bark.
10. Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials).
11. Patients on immunosuppression for kidney transplant.

Additional exclusion criteria for follow-up visits.

1. Patient informs of pregnancy.
2. Severe adverse reaction to the interventional product.

Where this trial is running

Abu Dhabi

• SEHA Kidney Care (SKC) — Abu Dhabi, United Arab Emirates (Recruiting)

Study contacts

• Principal investigator: Stephen G Holt, MD — Abu Dhabi Health Services Co. -SEHA
• Study coordinator: Stephen G Holt, MD

Conditions End Stage Renal Disease; Gum Arabic; ESRD; Acacia seyal and Acacia senegal