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

Launched by ABU DHABI HEALTH SERVICES COMPANY · Feb 14, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a natural substance called Gum Arabic (GA) on kidney function in adults with end-stage renal disease (ESRD) who are receiving dialysis. Researchers want to see if GA can help those patients who still produce some urine, known as residual renal function. This study is important because there isn't much information available about how GA might help people in this situation.

To participate, individuals must be at least 18 years old, diagnosed with ESRD, and have been on dialysis at least once a week for the past two weeks. They should also be able to produce a minimum of 200 milliliters of urine in a day. The study will last a maximum of 266 days, and participants need to be able to understand the study details and provide their consent to join. It's also important to know that certain people, such as those who are pregnant or planning to get pregnant soon, or those with specific health issues, may not be eligible to participate. If you or a loved one meet these criteria and are interested, this trial could be a chance to contribute to important research while exploring potential benefits of Gum Arabic for kidney health.

Gender

ALL

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.