Effect of Short Term Aliskiren Treatment in Kidney Transplant Patients

NCT01437943 | Terminated Phase 4 Results

• 1 other identifier: 2010P000005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Kidney Disease; Kidney Failure, Chronic

Keywords

Transplant; Failure; Kidney

Outcome Measures

Primary Outcomes (1)

• Effect of Aliskiren on Kidney Metabolism

  Evaluation of aliskiren on kidney metabolism by P-MR spectroscopy

  180 days (completion of treatment)

Study Arms (2)

Aliskiren

ACTIVE COMPARATOR

Aliskiren 150 mg daily for 180 days

Drug: Aliskiren

Placebo

PLACEBO COMPARATOR

Placebo identical to Aliskiren drug daily for 180 days

Drug: Placebo

Interventions

Aliskiren DRUG

Take 1 tablet (150 mg) by mouth daily for 180 days

Also known as: Tekturna

Aliskiren

Placebo DRUG

Take 1 tablet (0 mg) daily for 180 days.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 If a patient experiences such an event between Visit 1 and randomization at Visit 3, he/she should be withdrawn from the screening phase.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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Novartis: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Kidney Failure, Chronic

Interventions

aliskiren

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

In December 2011, all studies involving Aliskiren were terminated by Novartis after interim analysis of the ALTITUDE trial.

Results Point of Contact

• Title: Anil Chandraker, MD
• Organization: Brigham and Women's Hospital

achandraker@partners.org

617-732-7412

Study Officials

• Anil Chandraker, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of Renal Transplantation

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 21, 2011
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 1, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-03

Locations

US (1)