NCT06836206 The Effect of Gum Arabic (GA) on Residual Renal Function in Adult Dialysis Patients in Abu Dhabi
| NCT ID | NCT06836206 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Abu Dhabi Health Services Company |
| Condition | End Stage Renal Disease (ESRD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-02-03 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-02-03 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Stephen G Holt, MD
PRINCIPAL INVESTIGATOR
Abu Dhabi Health Services Co. -SEHA
Frequently Asked Questions
Who can join the NCT06836206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying End Stage Renal Disease (ESRD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06836206 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06836206 currently recruiting?
Yes, NCT06836206 is actively recruiting participants. Contact the research team at sholt@seha.ae for enrollment information.
Where is the NCT06836206 trial being conducted?
This trial is being conducted at Abu Dhabi, United Arab Emirates.
Who is sponsoring the NCT06836206 clinical trial?
NCT06836206 is sponsored by Abu Dhabi Health Services Company. The principal investigator is Stephen G Holt, MD at Abu Dhabi Health Services Co. -SEHA. The trial plans to enroll 40 participants.