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NCT Number: NCT07176663

Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure

Diabetes management presents a complex clinical scenario marked by several challenges, especially in chronic kidney failure. These include navigating potential drug interactions between oral antidiabetic therapies and other agents. Furthermore, these patients may experience various adverse drug effects, such as lactic acidosis, electrolyte abnormalities such as hypomagnesemia, fluid retention, and lipid derangements, which can further augment overall morbidity. Consequently, many patients receive insulin. However, prolonged intensive insulin therapy may be linked to several adverse outcomes, including an increased risk of hypoglycemia and weight gain.

Hence, a common practice is to transition to medications commonly used other populations of patients. With their established benefits on glycemic control, cardiovascular health, renal benefits, and weight management, in conjunction with the aforementioned adverse effects associated with other oral antidiabetics agents, glucagon-like peptide-1 receptor agonists have emerged as an attractive therapeutic option for patients with kidney failure.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nooshin Dalili

Tehran, 1666663421, Iran

About this study

Investigators will conduct a single-center clinical trial at Labafinezhad Hospital in Tehran, Iran. Initially, 15 stable chronic kidney failure patients with a glomerular filtration rate < 30 cc/min but not on dialysis, will receive tirzepatide(Spartina) therapy. Inclusion criteria consisted of age ≥18 years and a history of chronic kidney failure with preexisting diabetes or obesity with a body mass index over 27.

. Major exclusion criteria included similar drug therapy for a duration of less than 3 months and nonadherence to tirzepatide therapy. After an initial screen, investigators will enroll 15 patients who meet the inclusion criteria. The project is pending Institutional Research Ethics Committee of Shahid Beheshti University of Medical Sciences approval.

Data collection at baseline involves gathering demographic information, including age, sex, weight, height, and blood type group. Furthermore, investigators will obtain information related to past medical history, including the presence of preexisting diabetes mellitus, the onset of diabetes mellitus, and the requirement of insulin therapy. Efficacy endpoints include alterations in weight, body mass index (in kilograms divided by height in meters squared), serum triglycerides, insulin requirements, fasting plasma glucose, and estimated glomerular filtration rate, computed based on the Chronic Kidney Disease Epidemiology 2021 collaboration formula. For safety outcomes, investigators will review serum lipase, thyroid-stimulating hormone levels, and liver function tests at baseline and after tirzepatide therapy. Investigators will also report on all-cause mortality. Efficacy and safety endpoint data will be collected initially at baseline (therapy initiation) and at the end of 1 and 3d months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

age ≥18 years and history of diabetes or BMI over 27

Exclusion criteria

Previous usage of similar therapy for less than 3 months owing to the inability to capture all efficacy and safety endpoints within this brief timeframe and/or nonadherence to tirzepatide therapy

Treatment and study plan

Tirzepatide

Drug

2.5 mg weekly first month and 5 mg weekly for two month

Other names: Spartina

Primary outcomes

  1. weight loss

    Time frame: kilogram of weight loss measured by same scale one and three month after injection

Study contacts

Contact information is provided by the study sponsor or research team.

Nooshin Dalili, MD

CONTACT

[email protected]

00989122404331

Nooshin Dalili, MD

CONTACT

00989122404331

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study title

Safety and Effectiveness of Tirzepatide(Spartina )in Chronic Kidney Failure a Single-center Study

Acronym: Tirzepatide

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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