Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07423247

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

Led by Shahid Beheshti University of Medical Sciences · Updated on 2026-02-20

30

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Tirzepatide (Spartina) in Obese Kidney Transplant Recipients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Kidney transplant recipient with at least 12 months since transplantation
  • Body mass index (BMI) of 27 kg/m² or higher
  • Stable graft function in the last 3 months with serum creatinine variation less than 20%
  • Stable immunosuppressive medication regimen
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of pancreatitis
  • Severe gastroparesis
  • History of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m²
  • Acute kidney rejection episode within the past 6 months
  • Any condition that the investigator considers may interfere with participation or safety

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nooshin Dalili

Tehran, Iran

Actively Recruiting

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Research Team

N

Nooshin Dalili, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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