Kidney Transplant Clinical Trials

Clinical trials related to Kidney Transplant Procedure

Safety and Efficacy of Tirzepatide (Spartina) in Obese Kidney Transplant Recipients: A Pilot Study on Weight Loss, Gastrointestinal Tolerability, and Graft Function

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

Post-transplant obesity is a common complication after kidney transplantation, largely attributed to recovery from uremia, increased appetite, sedentary lifestyle, and long-term corticosteroid exposure. Obesity in kidney transplant recipients increases the risk of cardiovascular disease, post-transplant diabetes mellitus (PTDM), and may contribute to graft injury through hyperfiltration-related mechanisms, potentially leading to reduced graft survival. Current approaches for weight management in transplant recipients, including lifestyle modification, are often insufficient, while bariatric surgery carries considerable risks and concerns regarding altered absorption of immunosuppressive medications. Tirzepatide (Iranian brand name: Spartina), the first dual agonist of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, has demonstrated superior effects on weight reduction and glycemic control compared with earlier GLP-1 receptor agonists in the general population. However, its use in kidney transplant recipients requires careful evaluation due to potential gastrointestinal adverse effects, dehydration risk, and possible interaction with calcineurin inhibitor absorption caused by delayed gastric emptying. This prospective single-arm pilot clinical trial aims to assess the preliminary safety and efficacy of tirzepatide in obese kidney transplant recipients with stable graft function. Outcomes include changes in anthropometric indices, percent weight change, gastrointestinal tolerability, immunosuppressive drug trough levels, and graft function over 24 weeks of treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Kidney transplant recipient with ≥12 months since transplantation

• BMI ≥ 27 kg/m²

• Stable graft function in the last 3 months (serum creatinine variation \< 20%)

• Stable immunosuppressive regimen

• Ability to provide written informed consent

Locations
Other Locations
Islamic Republic of Iran
Nooshin Dalili
RECRUITING
Tehran
Contact Information
Primary
Nooshin Dalili, MD
dr.nooshindalili@gmail.com
00989122404331
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2026-09
Participants
Target number of participants: 30
Treatments
Experimental: Tirzepatide(Spartina)
Route: Subcutaneous injection (SC)~* Frequency: Once weekly~* Duration: 24 weeks~* Dose escalation:~* Weeks 1-4: 2.5 mg weekly~* Weeks 5-8: 5 mg weekly (if tolerated)~* Weeks 9-24: Continue 5 mg weekly or increase to 7.5 mg weekly based on tolerability and physician judgment
Related Therapeutic Areas
Sponsors
Leads: Shahid Beheshti University of Medical Sciences

This content was sourced from clinicaltrials.gov