NCT01541267

Brief Summary

The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
Last Updated

February 29, 2012

Status Verified

February 1, 2012

Enrollment Period

1.4 years

First QC Date

February 11, 2012

Last Update Submit

February 28, 2012

Conditions

Chronic Kidney DiseaseProteinuria

Keywords

aliskireneplerenontelmisartandirect renin inhibitorACE inhibitormineralocorticoid inhibitorproteinuriachronic kidney diseasesrenin-angiotensin-aldosterone system

Outcome Measures

Primary Outcomes (1)

  • Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms

    changes of UACR

    baseline and the end of 8 week treatments

Secondary Outcomes (2)

  • Difference in transforming growth factor beta (TGF-beta) between treatment arms

    baseline and the end of 8 week treatments

  • Difference in serum potassium and creatinine between treatment arms

    baseline and the end of 8 week treatments

Study Arms (3)

C - A - B

ACTIVE COMPARATOR

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Drug: aliskiren, eplerenon, telmisartan

B - A - C

ACTIVE COMPARATOR

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Drug: aliskiren, eplerenon, telmisartan

A - B - C

ACTIVE COMPARATOR

(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg

Drug: aliskiren, eplerenon, telmisartan

Interventions

aliskiren, eplerenon, telmisartanDRUG

aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)

A - B - CB - A - CC - A - B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-65 years
  • chronic non-diabetic proteinuric nephropathy
  • chronic kidney disease stage 1-3
  • stable proteinuria above 500 mg/24 hours
  • blood pressure above 125/75 mmHg and below 150/95 mmHg
  • no steroids or other immunosuppressive treatment for a minimum of six months before the study

You may not qualify if:

  • unstable coronary heart disease
  • decompensated congestive heart failure in the previous 6 months
  • episode of malignant hypertension or stroke in the history
  • diabetes
  • creatinine clearance below 30 ml/min
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicProteinuria

Interventions

aliskirenEplerenoneTelmisartan

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsUrination DisordersUrological ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bolesław Rutkowski, Professor

    Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 11, 2012

First Posted

February 29, 2012

Study Start

December 1, 2009

Primary Completion

May 1, 2011

Study Completion

November 1, 2011

Last Updated

February 29, 2012

Record last verified: 2012-02