Influence of pioglitazone for renal transplant function in diabetics

• Conditions: nephropathy after renal transplantation in patients with type 2 diabetes; MedDRA version: 8.1Level: LLTClassification code 10061835Term: Diabetic nephropathy

• Registration Number: EUCTR2006-004467-65-DE
• Lead Sponsor: Technical University Dresden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-renal transplant recipient (> 6 months after renal transplantation) with stable renal function (fluctuations of serum creatinin < 20% within 3 months prior to the screening examination)
-age between 30 and 75 years
-type 2 diabetes mellitus with acceptable glycemic control (HbA1c < 8%)
-estimated GFR >30 ml/min (MDRD formula)
-albuminuria > 30 mg / day

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- type 1 diabetes mellitus
- HbA1c > 8 %
- unstable renal function (any acute rejection episode within 3 months prior to the screening or chronic allograft nephropathy with fluctuation of serum creatinin > 20 %)
- pregnant or breastfeeeding women
- congestive heart failure > stage 1 NYHA
- uncontrolled hypertension
- hypo- or hyperthyreoidism

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified