Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

ConditionTirzepatide
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShahid Beheshti University of Medical Sciences

About this trial

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 criteria

Qualifiers

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%)

Disqualifiers

History of pancreatitis

Severe gastroparesis

History of medullary thyroid carcinoma (MTC) or MEN2 syndrome

eGFR < 30 mL/min/1.73m²

Trial design

Treatments tested in this trial

  • Tirzepatide

Treatment groups

30 Participants
are divided into 1 treatment group