Safety & Tolerability Study of CTP-499 in Patients With Moderate Chronic Kidney Disease

A Multi Center, Double-Blind, Two-Arm,Placebo Controlled, Randomized Safety and Tolerability Study of CTP-499 in Non-Dialysis Patients With Stage 3 Chronic Kidney Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01460199

Enrollment

Registered

2011-10-26

Start date

2011-08-31

Completion date

2011-12-31

Last updated

2013-05-24

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

Conditions

Stage 3 Chronic Kidney Disease

Brief summary

This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.

Detailed description

This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2

Interventions

DRUGCTP-499

3 X 200 mg tablets (QD for 2 weeks) 3 x 200 mg tablets (BID for 2 weeks)

DRUGplacebo

tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient has a diagnosis of chronic kidney disease * If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks * Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg

Exclusion criteria

* Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder * Patient has acute, active and/or current unstable renal impairment disease * Patient has been hospitalized for acute renal failure in the past year * Patient has active malignancy or a history of neoplastic disease * Patient has QTc interval \> 450 milliseconds * Patient is currently on cytotoxic or other immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame	Description
Safety measures	4 weeks	number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams

Secondary

Measure	Time frame	Description
Pharmacokinetic Profile	4 weeks	Time Frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 18, 24 hours Cmax, Tmax, Area Under the Curve (AUC)

Countries

United States

Outcome results

None listed

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