Effect of Pioglitazone on Serum FGF-23 Levels in Patients with Diabetic Kidney Disease: A Randomized Controlled Trial

Phase 4

Completed

• Conditions: T2DM CKD stage 3-4 patients; T2DM; CKD stage 3-4 patients

• Registration Number: TCTR20210316009
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-10-30
• Study Start: 2021-03-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. age of 18 years or more
2. T2DM with stable HbA1c 6-8%
3. eGFR 15-59 ml/min/1.73m2 with stable renal function in 12 weeks
4. Stable calcium and phosphate level

Exclusion Criteria

1. history of AKI in 12 weeks
2. History of heart failure or volume overload within 12 weeks
3. History of frequent hypoglycemia
4. History of fracture or bladder cancer
5. Previous pioglitazone and insulin use
6. Previous side effects of pioglitazone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
reduction of serum intact FGF-23 at 16 weeks after end of intervention laboratory test

Secondary Outcome Measures

Name	Time	Method
changes of serum calcium, phosphate, intact PTH, HbA1c and HOMA-IR 16 weeks laboratory test