A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients

A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01487109

Enrollment

170

Registered

2011-12-07

Start date

2012-01-31

Completion date

2015-01-31

Last updated

2021-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes, chronic kidney disease

Brief summary

This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).

Detailed description

There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 weeks.

Interventions

DRUGCTP-499

600 mg tablet twice daily

DRUGPlacebo

Matching placebo tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female 18 years or older * Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease * On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks * Not expected to start dialysis for one year * Patient has blood pressure less than or equal to 145/90 mm Hg * Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g * Patient has glycosylated hemoglobin A1c less than or equal to 10.5%

Exclusion criteria

* Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses * Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines * Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year * Patient has active malignancy or history of neoplastic disease * Patient has a QTc interval greater than 450 milliseconds * Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening * Patient is breast feeding or pregnant

Design outcomes

Primary

Measure	Time frame
To assess the change in urinary albumin to creatinine ratio	Weeks 16, 20, 24

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026