TrialGlobe

Clinical trial

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07423247

Recruiting nowPhase 4Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionTirzepatide

Full registry criteria

Inclusion Criteria: * 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 Exclusion Criteria: * History of pancreatitis * Severe gastroparesis * History of medullary thyroid carcinoma (MTC) or MEN2 syndrome * eGFR \< 30 mL/min/1.73m² * Acute rejection episode within the past 6 months * Any condition judged by the investigator to interfere with study participation or safety

Treatments and study arms

Tirzepatide

Drug

* 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

Primary outcomes

Percent Change in Body Weight From Baseline at Week 24Baseline to Week 24

Percent change in body weight compared to baseline

Incidence of Gastrointestinal Adverse EventsBaseline to Week 24 (monthly assessment)

Number of participants with gastrointestinal adverse events ( nausea, vomiting, diarrhea, constipation, abdominal pain) graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Change in Serum CreatinineBaseline to Week 24

Change from baseline in serum creatinine (mg/dl).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Nooshin Dalili🌐 Tehran, Iran
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