Peroxisome Proliferator-Activated Receptor-Gamma Activation in Peritoneal Dialysis Patients

NCT00745225 | Completed Phase 4

• 1 other identifier: A111-101
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

To study whether peroxisome proliferator-activated receptor-gamma activation in peritoneal dialysis patients will reduce inflammation, atherosclerosis, calcification and improve survival of peritoneal dialysis patients

Conditions

End-stage Renal Disease

Keywords

peritoneal dialysis, cardiovascular, PPAR-gamma

Outcome Measures

Primary Outcomes (2)

• Change in carotid intima-media thickness

  Change in carotid intima-media thickness

  over 48 weeks

• change in flow mediated dilatation (marker of endothelial function)

  change in flow mediated dilatation (marker of endothelial function)

  over 48 weeks

Secondary Outcomes (21)

• change in aortic pulse wave velocity

  over 96 weeks

• change in augmentation index-heart rate adjusted

  over 96 weeks

• change in nitroglycerin-mediated dilatation

  over 48 weeks

• change in coronary artery calcium score

  over 96 weeks

• change in heart valves calcium score

  over 96 weeks

Other Outcomes (6)

• overall survival

  over 96 weeks

• major adverse cardiovascular event-free survival

  over 96 weeks

• Fluid overload/heart failure event-free survival

  over 96 weeks

Study Arms (2)

Active intervention arm

EXPERIMENTAL

Peroxisome proliferator activator receptor gamma treatment, Pioglitazone

Drug: Pioglitazone

placebo pill

PLACEBO COMPARATOR

placebo comparator

Drug: placebo comparator

Interventions

Pioglitazone DRUG

pioglitazone 15mg daily for 12 weeks, then 30mg daily for 84 weeks

Also known as: Actos

Active intervention arm

placebo comparator DRUG

1 capsule daily, 96 weeks.

Also known as: Placebo

placebo pill

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both prevalent patients or patients newly started on continuous peritoneal dialysis, with or without diabetes mellitus will be considered eligible for study entry.
• For patients newly started on chronic peritoneal dialysis, they will be suitable for recruitment into the study after one month on peritoneal dialysis.
• Patients who provide informed consent for the study

You may not qualify if:

• Patients with underlying active malignancy
• Patients with chronic liver disease or liver cirrhosis
• Patients with active infections
• Patients with other chronic active inflammatory disease such as systemic lupus erythematosus, rheumatoid arthritis
• Patients who refuse study participation
• Patients with underlying congenital heart disease or rheumatic heart disease
• Patients with poor general condition
• Patients with plans for living related kidney transplant within 2 years
• Female patients with pregnancy
• Patients with history of recurrent hypoglycemia
• Patients with Class III and IV congestive heart failure
• Patients already receiving glitazones treatment at the screening visit

Sponsors & Collaborators

• The University of Hong Kong: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Queen Mary Hospital, Tung Wah Hospital

Hong Kong, 0000, Hong Kong

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angela YM Wang, MD, PhD, FRCP

  University of Hong Kong, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind randomized placebo-controlled trial, all parties are masked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Double-blind randomized placebo-controlled trial

Study Record Dates

• First Submitted: September 1, 2008
• First Posted: September 3, 2008
• Study Start: February 1, 2006
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 8, 2021

Record last verified: 2021-10

Locations

HK (1)