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

NCT ID: NCT07176663

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2026-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spartina

weekly injection of Tirzepatide (Spartina)

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

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

Interventions

Tirzepatide

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

Intervention Type: DRUG

Other Intervention Names

Spartina

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

nooshin dalili

Associate Professor of Nephrology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nooshin Dalili, MD

Role: PRINCIPAL_INVESTIGATOR

SBMU

Locations

Nooshin Dalili

Tehran, , Iran

Countries

Iran

Central Contacts

Nooshin Dalili, MD

Role: CONTACT

dr.nooshindalili@gmail.com

00989122404331

Nooshin Dalili, MD

Role: CONTACT

00989122404331

Other Identifiers

SBMU-1404-06

Identifier Type: -

Identifier Source: org_study_id