Suspended

Aldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease

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What is being tested

Aliskiren

+ Valsartan

Drug
Who is being recruted

Urogenital Diseases+14

+ Autoimmune Diseases

+ Diabetes Mellitus

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorColumbia University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

This is a randomized, open-label, three-arm study comparing Diovan (valsartan, an ARB), Tekturna (aliskiren, a DRI), and the combination of valsartan + aliskiren (i.e. ARB + DRI). One hundred twenty subjects (40 per arm) will be treated with Tekturna, Diovan, or a combination of both drugs for 9 months on top of their usual antihypertensive treatment. Changes in urinary aldosterone excretion will be monitored during therapy to measure the incidence of aldosterone breakthrough, defined as any sustained positive change from baseline urinary aldosterone excretion by the completion of the 9-month study period. This frequency measure will be compared during ARB, DRI, and ARB + DRI therapy. Changes in urinary protein excretion will also be monitored alongside the urinary aldosterone levels to determine whether aldosterone breakthrough is associated with refractory proteinuria. This is an innovative study that will be the first to (1) examine aldosterone breakthrough during DRI therapy, and (2) explore whether addition of a DRI to an ARB protects against aldosterone breakthrough. In addition, this will be the first study to examine whether DRI therapy (alone or in combination with ARB) is effective therapy for hypertension in patients with non-diabetic proteinuric kidney disease.

Official TitleAldosterone Breakthrough During Diovan (Valsartan), Tekturna (Aliskiren), and Combination (Valsartan+Aliskiren) Anti-hypertensive Therapy in Patients With Proteinuric Kidney Disease
NCT01129557
Principal SponsorColumbia University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

46 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesDiabetes MellitusDiabetic NephropathiesEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisGlomerulonephritis, IGAGlomerulosclerosis, Focal SegmentalImmune System DiseasesKidney DiseasesNephritisUrologic DiseasesGlomerulonephritis, MembranousDiabetes ComplicationsFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Proteinuria > 300 mg/day

Normal to mildly reduced kidney function (eGFR > 45 ml/min/1.73m2)

Systolic blood pressure >130 mm Hg

Diastolic blood pressure >70 mm Hg

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17 exclusion criteria prevent from participating
Concomitant use of cyclosporine (which can interact with aliskiren)

Inability to undergo 6 week washout period if already on RAAS-blocking drug(s) (includes renin inhibitor, ACE-inhibitor, ARB, and mineralocorticoid receptor blocker)

eGFR < 45 ml/min/1.73m2

Urine protein excretion < 300 mg/day

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months

Group II

Active Comparator
Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily \& Diovan (Valsartan), an angiotensin receptor (ARB) 160 mg by mouth once daily for 9 months

Group III

Active Comparator
Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Columbia University Medical Center

New York, United StatesOpen Columbia University Medical Center in Google Maps
SuspendedOne Study Center