- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01437943
Effect of Short Term Aliskiren Treatment in Kidney Transplant Patients
March 21, 2017 updated by: Anil K. Chandraker, MD, Brigham and Women's Hospital
P-MR Spectroscopy Evaluation of the Effect of Short-Term Treatment With Aliskiren on Kidney β-ATP/Pi Level in Kidney Transplant Patients
The purpose of this study is to evaluate the effect of a short-term aliskiren treatment on kidney metabolism in patients at high risk for developing kidney dysfunction (i.e.
kidney transplanted patients).
The study is aimed at evaluating if any effect on kidney metabolism [using proton MR Spectroscopy(1H-MRS)] can be detected following a 6 months treatment with aliskiren regardless of its anti-hypertensive role.
1H-MRS can record a larger number of chemical species (up to 40) in the kidney, and monitor changes according to the pathologic state and health of the transplanted kidney.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Stable patients with end stage renal disease receiving cadaveric kidney transplantation will be enrolled. Patients must have at least 6 months of follow-up to be included in the study. Patients must have stable creatinine levels in the last 6 months (no change>0.5 mg/dl).
- Patients with a systolic blood pressure of 120 or above
Exclusion Criteria:
- Serum potassium > 5.0 mmol/L (at the visit directly preceding Randomization);
- History of any cardiovascular event (stroke, TIA, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1. If a patient experiences such an event between Visit 1 and randomization at Visit 3, he/she should be withdrawn from the screening phase. If suitable, the patient can be re-screened at a later stage;
- Hypertension (at enrollment): any patient with msSBP ≥ 170 mmHg or msDBP ≥ 110 mmHg;
- Congestive heart failure NYHA class III and IV;
- Concomitant treatment with two (2) or more renin-angiotensin-aldosterone system blocking agents, e.g. ACEI, ARB or aldosterone-antagonist;
- Unstable serum creatinine, no patients with creatinine >2.5 mg/dl will be enrolled;
- Second (II) or third (III) degree heart block without a pacemaker;
- Concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia;
- Clinically significant valvular heart disease;
- Known renal artery stenosis;
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following: (i) History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery > 6 months prior to Visit 1 are allowed to participate); (ii) Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase; (iii) Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3 x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
- History of malignancy other than basal cell skin cancer within the past five years.
- Any concurrent life threatening condition with a life expectancy less than 2 years.
- History or evidence of drug or alcohol abuse within the last 12 months.
- Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
- History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
- History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
- Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
- Persons directly involved in the execution of this protocol.
- Pregnant or nursing (lactating) women
- Women of Child-Bearing Potential (WOCBP) unless postmenopausal for at least one year, surgically sterile or using effective methods of contraception as defined by local Health Authorities.
- Treatment with Cyclosporine.
Exclusion criteria include MR contraindications:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pregnant volunteers
- pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions
- any greater than normal potential for cardiac arrest
- subjects less than 18 years of age.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Aliskiren
Aliskiren 150 mg daily for 180 days
|
Take 1 tablet (150 mg) by mouth daily for 180 days
Other Names:
|
Placebo Comparator: Placebo
Placebo identical to Aliskiren drug daily for 180 days
|
Take 1 tablet (0 mg) daily for 180 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Aliskiren on Kidney Metabolism
Time Frame: 180 days (completion of treatment)
|
Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy
|
180 days (completion of treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Anil Chandraker, MD, Brigham and Women's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
September 20, 2011
First Submitted That Met QC Criteria
September 20, 2011
First Posted (Estimate)
September 21, 2011
Study Record Updates
Last Update Posted (Actual)
May 1, 2017
Last Update Submitted That Met QC Criteria
March 21, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010P000005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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