Chronic Kidney DiseasePhase 3Dapa-CKDNCT03036150

A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease

A Phase 3 study testing Dapagliflozin in people with Chronic Kidney Disease, run by AstraZeneca at 390 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 4,304 participants
Where: 390 sitesin 21 countries
Study dates: 2 Feb 2017to 12 Jun 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed informed consent prior to any study specific procedures
Female or male aged ≥18 years at the time of consent
eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

Who cannot join

Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
History of organ transplantation
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus
New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

Trial locations and contacts

390 sites in 21 countries.

Country

City, postcode or hospital

390 sites in 21 countries

United States55 sites

Research Site
Albany, New York, 12208
Research Site
Asheville, North Carolina, 28801
Research Site
Atlanta, Georgia, 30342-1797
Research Site
Augusta, Georgia, 30904
Research Site
Aurora, Colorado, 80045
Research Site
Birmingham, Alabama, 35233
Research Site
Boston, Massachusetts, 02111
Research Site
Boynton Beach, Florida, 33435
Research Site
Boynton Beach, Florida, 33472
Research Site
Burke, Virginia, 22015
Research Site
Charlotte, North Carolina, 28207
Research Site
Chicago, Illinois, 60643
Research Site
Cincinnati, Ohio, 45219
Research Site
Denver, Colorado, 80246
Research Site
Detroit, Michigan, 48202
Research Site
Duluth, Minnesota, 55805
Research Site
El Paso, Texas, 79935
Research Site
Flint, Michigan, 48504
Research Site
Fort Worth, Texas, 76116
Research Site
Fort Worth, Texas, 76117
Research Site
Fort Worth, Texas, 76164
Research Site
Greer, South Carolina, 29651
Research Site
Hawaiian Gardens, California, 90716
Research Site
Hickory, North Carolina, 28601
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32224
Research Site
Jersey Shore, Pennsylvania, 17740
Research Site
Kingsport, Tennessee, 37660
Research Site
Lomita, California, 90717
Research Site
Los Angeles, California, 90022
Research Site
Manassas, Virginia, 20110
Research Site
Maumee, Ohio, 43537
Research Site
Metairie, Louisiana, 70006
Research Site
Miami, Florida, 33015
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33014
Research Site
Naples, Florida, 34102
Research Site
Nashville, Tennessee, 37232
Research Site
New Bern, North Carolina, 28562
Research Site
New Port Richey, Florida, 34652
Research Site
Newport News, Virginia, 23606
Research Site
Odessa, Texas, 79761
Research Site
Omaha, Nebraska, 68105
Research Site
Palo Alto, California, 94304
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
San Dimas, California, 91773
Research Site
San Ramon, California, 94582
Research Site
Tacoma, Washington, 98405
Research Site
Topeka, Kansas, 66606
Research Site
Vista, California, 92083
Research Site
Wichita, Kansas, 67214
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Japan49 sites

Research Site
Amagasaki-shi, 660-8550
Research Site
Asahikawa-shi, 070-8644
Research Site
Beppu-shi, 874-0011
Research Site
Bunkyō City, 113-8431
Research Site
Chiba, 260-8712
Research Site
Chūōku, 103-0002
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Daito-shi, 574-0074
Research Site
Fujisawa-shi, 251-8550
Research Site
Fukuoka, 810-0065
Research Site
Higashiibaraki-gun, 311-3193
Research Site
Iizuka-shi, 820-8505
Research Site
Kamakura-shi, 247-8533
Research Site
Kanazawa, 920-8650
Research Site
Kawachinagano-shi, 586-8521
Research Site
Kawasaki-shi, 211-8510
Research Site
Kobe, 654-0155
Research Site
Koga-shi, 811-3195
Research Site
Koshigaya-shi, 343-8577
Research Site
Kumamoto, 860-0008
Research Site
Kurashiki, 701 0192
Research Site
Matsumoto-shi, 390-8621
Research Site
Nagano, 388-8004
Research Site
Nagoya, 455-8530
Research Site
Nagoya, 456-0058
Research Site
Nagoya, 457-8511
Research Site
Naha, 902-0061
Research Site
Neyagawa, 572-0015
Research Site
Niigata, 951-8520
Research Site
Ōita, 870-0039
Research Site
Okayama, 700-8558
Research Site
Okayama, 701-1192
Research Site
Osaka, 530-8480
Research Site
Osaka, 540-0006
Research Site
Osaka, 558-8558
Research Site
Saga, 840-8571
Research Site
Sapporo, 063-0005
Research Site
Shizuoka, 420-8630
Research Site
tabashi City, 173-8610
Research Site
Takarazuka-shi, 665-0861
Research Site
Toride-shi, 302-0022
Research Site
Tsu, 514-1101
Research Site
Tsu, 514-8507
Research Site
Tsuchiura-shi, 300-0028
Research Site
Ueda-shi, 386-8610
Research Site
Uji-shi, 611-0041
Research Site
Yaizu-shi, 425-8505
Research Site
Yokohama, 232-0024

Other trials in Japan

China32 sites

Research Site
Baotou, 14010
Research Site
Beijing, 100034
Research Site
Beijing, 100044
Research Site
Beijing, 102206
Research Site
Changchun, 130021
Research Site
Changchun, 130041
Research Site
Changsha, 410008
Research Site
Chengdu, 610041
Research Site
Chengdu, 610072
Research Site
Foshan, 528000
Research Site
Fuzhou, 350025
Research Site
Guangzhou, 510000
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510515
Research Site
Guiyang, 550004
Research Site
Jilin City, 132000
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330006
Research Site
Nanjin, 210029
Research Site
Nanjing, 210009
Research Site
Nanning, 530021
Research Site
Ningbo, 315010
Research Site
Shanghai, 200025
Research Site
Shanghai, 200040
Research Site
Shanghai, 200090
Research Site
Shanghai, 200127
Research Site
Shengyang, 110004
Research Site
Shenzhen, 518053
Research Site
Tianjin, 300052
Research Site
Wuhan, 430033
Research Site
Yinchuan, 750004
Research Site
Yueyang, 414000

Other trials in China

Argentina21 sites

Research Site
Buenos Aires, ARG 1425
Research Site
Buenos Aires, C1425BGN
Research Site
Buenos Aires, C1429BWN
Research Site
CABA, C1119ACN
Research Site
CABA, C1120AAC
Research Site
Ciudad Autonoma Buenos Aires, 1093
Research Site
Ciudad Autonoma de Buenos Aire, C1407GTN
Research Site
Córdoba, 5000
Research Site
Córdoba, X5006CBI
Research Site
Córdoba, X5016LIG
Research Site
Corrientes, W3400AMZ
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600FZN
Research Site
Nueve de Julio, B6500EZL
Research Site
Rosario, S2000DEJ
Research Site
San Luis, D5700CTA
Research Site
San Miguel de Tucumán, 4000
Research Site
San Miguel de Tucumán, T4000ICL
Research Site
San Nicolás, B2900DMH
Research Site
Santa Fe, 3000
Research Site
Santa Rosa, 6300

Other trials in Argentina

Canada21 sites

Research Site
Brampton, Ontario, L6S 0C6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Concord, Ontario, L4K 4M2
Research Site
Edmonton, Alberta, T6H 2L4
Research Site
Etobicoke, Ontario, M9R 4E1
Research Site
Gatineau, Quebec, J8Y 6S8
Research Site
Greenfield Park, Quebec, J4V 2H1
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Kingston, Ontario, K7L 2V7
Research Site
London, Ontario, N6A 5A5
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Oakville, Ontario, L6K 3V3
Research Site
Oshawa, Ontario, L1G 2B9
Research Site
Pointe-Claire, Quebec, H9R 3J1
Research Site
Red Deer, Alberta, T4N 6V7
Research Site
Sherbrooke, Quebec, J1H 5N4
Research Site
Smiths Falls, Ontario, K7A 4W8
Research Site
Toronto, Ontario, M4C 5T2
Research Site
Toronto, Ontario, M5G 2N2
Research Site
Vancouver, British Columbia, V6Z 1Y6

Other trials in Canada

Ukraine21 sites

Research Site
Cherkasy, 18009
Research Site
Chernivtsі, 58018
Research Site
Dnipro, 49005
Research Site
Dnipro, 49102
Research Site
Ivano-Frankivsk, 76008
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv Region, 61039
Research Site
Kharkiv Region, 61103
Research Site
Kharkiv Region, 61166
Research Site
Kyiv, 02091
Research Site
Kyiv, 02125
Research Site
Kyiv, 04053
Research Site
Kyiv, 4050
Research Site
Lutsk, 43005
Research Site
Odesa, 65025
Research Site
Poltava, 36011
Research Site
Rivne, 33027
Research Site
Ternopil, 46000
Research Site
Vinnytsia, 21001
Research Site
Vinnytsia, 21018
Research Site
Zaporizhzhya, 69600

Other trials in Ukraine

Russia20 sites

Research Site
Chelyabinsk, 454091
Research Site
Kazan', 420012
Research Site
Kemerovo, 650002
Research Site
Kemerovo, 650066
Research Site
Krasnoyarsk, 660062
Research Site
Moscow, 123995
Research Site
Omsk, 644112
Research Site
Perm, 614000
Research Site
Perm, 614068
Research Site
Rostov-on-Don, 344022
Research Site
Saint Petersburg, 194354
Research Site
Saint Petersburg, 196601
Research Site
Saint Petersburg, 199106
Research Site
Saratov, 410053
Research Site
Tver', 170036
Research Site
Ufa, 450071
Research Site
Vladikavkaz, 362007
Research Site
Volgograd, 400131
Research Site
Yaroslavl, 150062
Research Site
Yekaterinburg, 620039

Other trials in Russia

India19 sites

Research Site
Ahmedabad, 380016
Research Site
Bangalore, 560002
Research Site
Calicut, 673008
Research Site
Chennai, 600001
Research Site
Ernākulam, 683594
Research Site
Hyderabad, 500018
Research Site
Kanpur, 208002
Research Site
Kolkata, 700020
Research Site
Lucknow, 226003
Research Site
Lucknow, 226005
Research Site
Madurai, 625020
Research Site
Maharashtra, 411013
Research Site
Mangalore, 575003
Research Site
Nagpur, 440003
Research Site
Nagpur, 440012
Research Site
New Delhi, 110017
Research Site
Pune, 411001
Research Site
Pune, 411040
Research Site
Vijayawada, 522002

Other trials in India

Poland18 sites

Research Site
Bielsko-Biala, 43-300
Research Site
Bochnia, 32-700
Research Site
Chorzów, 41-500
Research Site
Ciechanów, 06-400
Research Site
Katowice, 40-081
Research Site
Katowice, 40-648
Research Site
Krakow, 31-156
Research Site
Krakow, 31-530
Research Site
Legnica, 59-220
Research Site
Lodz, 92-213
Research Site
Oława, 55-200
Research Site
Olsztyn, 10-561
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Poznan, 60-821
Research Site
Ruda Śląska, 41-709
Research Site
Rzeszów, 35-055
Research Site
Szczecin, 70-111
Research Site
Tczew, 83-110

Other trials in Poland

South Korea16 sites

Research Site
Ansan-si, 15355
Research Site
Deagu, 41944
Research Site
Goyang-si, 10380
Research Site
Goyang-si, 10444
Research Site
Gwangju, 61469
Research Site
Jeonju, 54907
Research Site
Seongnam-si, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 06273
Research Site
Seoul, 06591
Research Site
Seoul, 07061
Research Site
Seoul, 07804
Research Site
Seoul, 07985
Research Site
Uijeongbu-si, 11765
Research Site
Wŏnju, 26426

Other trials in South Korea

Mexico15 sites

Research Site
Aguascalientes, 20230
Research Site
Cuernavaca, 62448
Research Site
Culiacán, 80230
Research Site
D.F, 14000
Research Site
Durango, 34000
Research Site
Guadalajara, 44600
Research Site
Mazatlán, 82000
Research Site
Mazatlán, 82110
Research Site
México, 06700
Research Site
México, 06726
Research Site
México, 14080
Research Site
Minatitlán, 96730
Research Site
Monterrey, 64060
Research Site
Monterrey, 64460
Research Site
Saltillo, 25230

Other trials in Mexico

Peru15 sites

Research Site
Arequipa, AREQUIPA01
Research Site
Callao, CALLAO 2
Research Site
Chorrillos, Lima 9
Research Site
Cusco, CUSCO 01
Research Site
Ica
Research Site
Lima, 14
Research Site
Lima, 36
Research Site
Lima, L27
Research Site
Lima, LIMA 01
Research Site
Lima, LIMA 1
Research Site
Lima, LIMA 27
Research Site
Lima, LIMA 31
Research Site
Piura
Research Site
San Isidro, Lima 27
Research Site
San Miguel, Lima 32

Other trials in Peru

Brazil14 sites

Research Site
Botucatu, 18.618-686
Research Site
Campinas, 13010-001
Research Site
Caxias do Sul, 95070-560
Research Site
Curitiba, 80440-020
Research Site
Joinville, 89227-680
Research Site
Porto Alegre, 90020-090
Research Site
Porto Alegre, 90035-903
Research Site
Porto Alegre, 90610-000
Research Site
Salvador, 40415-065
Research Site
Santo André, 09090-790
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01228-000
Research Site
São Paulo, 04039-000
Research Site
São Paulo, 05403-000

Other trials in Brazil

Germany14 sites

Research Site
Aschaffenburg, 63739
Research Site
Bad Oeynhausen, 32545
Research Site
Berlin, 10117
Research Site
Dresden, 01307
Research Site
Düsseldorf, 40210
Research Site
Essen, 45136
Research Site
Frankfurt am Main, 60590
Research Site
Hanover, 30625
Research Site
Magdeburg, 39120
Research Site
München, 81675
Research Site
Münster, 48145
Research Site
Schweinfurt, 97421
Research Site
Tübingen, 72076
Research Site
Ulm, 89081

Other trials in Germany

Hungary12 sites

Research Site
Budapest, 1083
Research Site
Budapest, 1096
Research Site
Budapest, 1106
Research Site
Budapest, 1212
Research Site
Eger, 3300
Research Site
Gyula, 5700
Research Site
Kistarcsa, 2143
Research Site
Miskolc, 3526
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7624
Research Site
Szeged, 6720
Research Site
Velence, 2481

Other trials in Hungary

Spain11 sites

Research Site
A Coruña, 15006
Research Site
Barcelona, 08003
Research Site
Barcelona, 08035
Research Site
Burela (Lugo), 27880
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Madrid, 28041
Research Site
Málaga, 29010
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41071
Research Site
Valencia, 46010
Research Site
Valencia, 46017

Other trials in Spain

Philippines9 sites

Research Site
Bacolod, 6100
Research Site
Cebu, 6000
Research Site
Cebu City, 6000
Research Site
Dasmariñas, 4114
Research Site
Davao City, PH-8000
Research Site
Iloilo City, 5000
Research Site
Makati City, 1218
Research Site
Marikina City, 1800
Research Site
Quezon City, 1101

Other trials in Philippines

United Kingdom9 sites

Research Site
Cardiff, CF14 4XW
Research Site
Glasgow, G51 4TF
Research Site
Hull, HU3 2JZ
Research Site
Kent, BR6 8ND
Research Site
Leicester, LE5 4PW
Research Site
London, E1 1BB
Research Site
London, SE5 9RS
Research Site
Salford, M6 8HD
Research Site
Swansea, SA6 6NL

Other trials in United Kingdom

Vietnam8 sites

Research Site
Bien Hoa, 810000
Research Site
Hanoi, 10000
Research Site
Ho Chi Minh City, 10000
Research Site
Ho Chi Minh City, 7000000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000
Research Site
Ho Chi Minh City, 9000
Research Site
Hochiminh, 700000

Other trials in Vietnam

Denmark6 sites

Research Site
Aarhus, 8200
Research Site
Gentofte Municipality, 2820
Research Site
Herlev, 2730
Research Site
Hillerød, 3400
Research Site
København Ø, 2100
Research Site
Roskilde, 4000

Other trials in Denmark

Sweden5 sites

Research Site
Gothenburg, 413 45
Research Site
Malmö, 205 02
Research Site
Stockholm, 141 86
Research Site
Stockholm, 182 88
Research Site
Uppsala, 751 85

Other trials in Sweden

About this study

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Read the detailed description

This is an international, multicentre, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given once daily in addition to standard of care, to prevent the progression of chronic kidney disease (CKD) or cardiovascular (CV)/renal death.

Conditions: Chronic Kidney Disease
Being tested: Dapagliflozin, Placebo
Keywords: Chronic Kidney Disease (CKD), Cardiovascular Events (CV), Phase III outcome trial
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called Forxiga TM, Farxiga TM
10 mg or 5 mg tablets given once daily, per oral use.
PlaceboDrug
Placebo matching dapagliflozin 10 mg or 5 mg

Study groups in NCT03036150
Study group	Role	What they receive
Dapagliflozin	Experimental	Patients will be randomized 1:1 to either dapagliflozin or placebo. Receives: Drug: Dapagliflozin
Placebo	Placebo comparator	Placebo matching dapagliflozin. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
End Stage Renal Disease (ESRD) is defined as:
- Sustained eGFR <15 mL/min/1.73m2 or,
- Chronic dialysis treatment or,
- Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Measured: Up to 38.2 months

Secondary outcomes (3)

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.
End Stage Renal Disease (ESRD) is defined as:
- Sustained eGFR <15 mL/min/1.73m2 or,
- Chronic dialysis treatment or,
- Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Measured: Up to 38.2 months
Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.
The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Measured: Up to 38.2 months
Time to Death From Any Cause.
The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.
Measured: Up to 38.2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Feb 201712 Jun 2020

First posted30 Jan 2017 (estimated)
Study start2 Feb 2017
Primary completion12 Jun 2020
Study completion12 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (35)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 4,304 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03036150
Sponsor's protocol ID: D169AC00001
Other IDs: 2016-003896-24, 2016
Acronym: Dapa-CKD
Status last verified: Jun 2021
First submitted: 26 Jan 2017
Last updated: 7 Jul 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.
PubMed 41926219
Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.
PubMed 41661687
Heerspink HJL, Chertow GM, Rossing P, Correa-Rotter R, Sjostrom CD, Toto RD, Wheeler DC, Jongs N. Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1527-1535. doi: 10.2215/CJN.0000000810. Epub 2025 Sep 9.
PubMed 41128261
Bakker WM, Heerspink HJL, Jongs N, Correa-Rotter R, Rossing P, Toto RD, Wheeler DC, McMurray JJV, Langkilde AM, Gansevoort RT, Chertow GM, Vart P. Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD. J Am Soc Nephrol. 2026 Jan 1;37(1):101-109. doi: 10.1681/ASN.0000000776. Epub 2025 Jul 18.
PubMed 40679863
Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.
PubMed 40658498
Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.
PubMed 40526444
van Mil D, Vart P, Chertow GM, Gansevoort RT, Rossing P, Toto RD, Correa-Rotter R, Langkilde AM, Sjostrom CD, Wheeler DC, Heerspink HJL. Baseline, Early Changes, and Residual Albuminuria: Post Hoc Analysis of a Randomized Clinical Trial of Dapagliflozin in Chronic Kidney Disease. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1574-1584. doi: 10.2215/CJN.0000000000000550.
PubMed 39475817
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818
Fletcher RA, Herrington WG, Agarwal R, Mayne KJ, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Staplin N, Wheeler DC, Chertow GM, Heerspink HJL, Neuen BL. Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Cause-Specific Cardiovascular Death in Patients with CKD: A Meta-Analysis of CKD Progression Trials. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1180-1182. doi: 10.2215/CJN.0000000000000470. Epub 2024 Apr 16.
PubMed 38622766
Zhang Z, Heerspink HJL, Chertow GM, Correa-Rotter R, Gasparrini A, Jongs N, Langkilde AM, McMurray JJV, Mistry MN, Rossing P, Toto RD, Vart P, Nitsch D, Wheeler DC, Caplin B. Ambient heat exposure and kidney function in patients with chronic kidney disease: a post-hoc analysis of the DAPA-CKD trial. Lancet Planet Health. 2024 Apr;8(4):e225-e233. doi: 10.1016/S2542-5196(24)00026-3.
PubMed 38580424
Heerspink HJL, Stack AG, Terkeltaub R, Jongs N, Inker LA, Bjursell M, Maklad N, Perl S, Eklund O, Rikte T, Sjostrom CD, Perkovic V; SAPPHIRE Investigators. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial. J Am Soc Nephrol. 2024 May 1;35(5):594-606. doi: 10.1681/ASN.0000000000000326. Epub 2024 Feb 20.
PubMed 38564654
Koshino A, Schechter M, Chertow GM, Vart P, Jongs N, Toto RD, Rossing P, Correa-Rotter R, McMurray JJV, Gorriz JL, Isidto R, Kashihara N, Langkilde AM, Wheeler DC, Heerspink HJL. Dapagliflozin and Anemia in Patients with Chronic Kidney Disease. NEJM Evid. 2023 Jun;2(6):EVIDoa2300049. doi: 10.1056/EVIDoa2300049. Epub 2023 May 19.
PubMed 38320128
Yu MK, Vart P, Jongs N, Correa-Rotter R, Rossing P, McMurray JJV, Hou FF, Douthat W, Khullar D, Langkilde AM, Wheeler DC, Heerspink HJL, Chertow GM. Effects of Dapagliflozin in Chronic Kidney Disease Across the Spectrum of Age and by Sex. J Gen Intern Med. 2024 May;39(6):921-930. doi: 10.1007/s11606-023-08397-9. Epub 2023 Dec 14.
PubMed 38097862
Fletcher RA, Jongs N, Chertow GM, McMurray JJV, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Rockenschaub P, Rossing P, Correa-Rotter R, Toto RD, Vaduganathan M, Wheeler DC, Heerspink HJL, Neuen BL. Effect of SGLT2 Inhibitors on Discontinuation of Renin-angiotensin System Blockade: A Joint Analysis of the CREDENCE and DAPA-CKD Trials. J Am Soc Nephrol. 2023 Dec 1;34(12):1965-1975. doi: 10.1681/ASN.0000000000000248. Epub 2023 Oct 25.
PubMed 37876229
Heerspink HJL, Jongs N, Schloemer P, Little DJ, Brinker M, Tasto C, Karpefors M, Wheeler DC, Bakris G, Perkovic V, Nkulikiyinka R, Rossert J, Gasparyan SB. Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression. J Am Soc Nephrol. 2023 Dec 1;34(12):2025-2038. doi: 10.1681/ASN.0000000000000243. Epub 2023 Oct 24.
PubMed 37872654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
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What are the possible risks and benefits for me?
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What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
ClinicalTrials.gov ID: NCT03036150
Acronym / sponsor ID: Dapa-CKD / D169AC00001
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease (CKD), Cardiovascular Events (CV), Phase III outcome trial
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 4,304 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 2 Feb 2017 (actual)
Primary completion: 12 Jun 2020 (actual)
Study completion: 12 Jun 2020 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Posted 7 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: DapagliflozinPatients will be randomized 1:1 to either dapagliflozin or placebo.
Placebo	Placebo comparator	Drug: PlaceboPlacebo matching dapagliflozin.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of signed informed consent prior to any study specific procedures
Female or male aged ≥18 years at the time of consent
eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1
Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and ≤5000 mg/g at visit 1
Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

Key exclusion criteria (7 listed)

Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
History of organ transplantation
Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
Type 1 diabetes mellitus

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DapagliflozinAlso: Forxiga TM, Farxiga TM10 mg or 5 mg tablets given once daily, per oral use.	Drug	Dapagliflozin
PlaceboPlacebo matching dapagliflozin 10 mg or 5 mg	Drug	Placebo

Primary outcome

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.
Time frame: Up to 38.2 months
End Stage Renal Disease (ESRD) is defined as: * Sustained eGFR <15 mL/min/1.73m2 or, * Chronic dialysis treatment or, * Receiving a renal transplant The proportional hazards Cox regression model takes into account the time to the event. Data is reported as the numbers of subjects with the event and the Hazard ratio is included in the Statistical Analysis section attached to the Outcome Measure data table.

3 secondary outcomes

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or Renal Death.
Time frame: Up to 38.2 months
Time to the First Occurrence of Either of the Components of the Composite: CV Death or Hospitalization for Heart Failure.
Time frame: Up to 38.2 months
Time to Death From Any Cause.
Time frame: Up to 38.2 months

Results and safety

Results posted to the registry on 7 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin	2,152	2,142
Placebo	2,152	2,147

Primary outcome: Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death.

Time frame: Up to 38.2 months. Count of participants. Unit: Participants

Measure	Dapagliflozin n = 2152	Placebo n = 2152
Value	197	312

Dapagliflozin vs Placebo: Hazard Ratio (HR): 0.61 (95% CI 0.51 to 0.72), p < 0.0001, Regression, Cox

Population analysed: For the primary endpoint the Full Analysis Set was used. This included all patients who were randomized to study treatment. Patients were analyzed according to their randomized treatment assignment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 39.2 months. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapa 10 mg	633 of 2,149 (29.5%)	479 of 2,149 (22.3%)	107 of 2,152
Placebo	729 of 2,149 (33.9%)	500 of 2,149 (23.3%)	159 of 2,152

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41926219Moedt E, Koshino A, Jongs N, Ju W, Nair V, Kretzler M, Hansen MK, Arnott CG, Wheeler DC, Rossing P, Coca SG, Hammarstedt A, Greasley PJ, Bjornstad P, Bakker SJL, Heerspink HJL. Association of Urinary EGF with Kidney Outcomes and Effects of Sodium-Glucose Cotransporter 2 Inhibition. J Am Soc Nephrol. 2026 Apr 2. doi: 10.1681/ASN.0000001086. Online ahead of print.
Derived from this study: PubMed 41661687Howie AJ, Lalayiannis AD. The Oxford Classification Should Remain the Gold Standard for Classification of IgA Nephropathy: CON. Kidney360. 2026 Oct 1;7(10):2382-2384. doi: 10.34067/KID.0000001083. Epub 2026 Feb 9. No abstract available.
Derived from this study: PubMed 41128261Heerspink HJL, Chertow GM, Rossing P, Correa-Rotter R, Sjostrom CD, Toto RD, Wheeler DC, Jongs N. Effects of Dapagliflozin on Progression of CKD According to Different Rates of Pretrial eGFR Loss. Clin J Am Soc Nephrol. 2025 Nov 1;20(11):1527-1535. doi: 10.2215/CJN.0000000810. Epub 2025 Sep 9.
Derived from this study: PubMed 40679863Bakker WM, Heerspink HJL, Jongs N, Correa-Rotter R, Rossing P, Toto RD, Wheeler DC, McMurray JJV, Langkilde AM, Gansevoort RT, Chertow GM, Vart P. Effects of Dapagliflozin on Health-Related Quality of Life in Patients with CKD. J Am Soc Nephrol. 2026 Jan 1;37(1):101-109. doi: 10.1681/ASN.0000000776. Epub 2025 Jul 18.
Derived from this study: PubMed 40658498Oshima M, Buizen L, Jongs N, Levin A, Chertow GM, Wheeler DC, Heerspink HJL, Arnott C, Jardine MJ, Mahaffey KW, Pollock C, Herrington WG, Perkovic V, Neuen BL. Sodium-Glucose Cotransporter 2 Inhibition and Hospitalizations in Patients with CKD: A Meta-Analysis of Kidney Outcome Trials. Clin J Am Soc Nephrol. 2025 Jul 14;20(9):1206-1214. doi: 10.2215/CJN.0000000771.
Derived from this study: PubMed 40526444Jongs N, Gasparyan SB, Frison L, Schloemer P, Brinker M, Little DJ, Heerspink HJL. Use of eGFR Slope Thresholds as End Point Components in a Kidney Disease Progression Hierarchical Composite End Point. J Am Soc Nephrol. 2025 Dec 1;36(12):2421-2430. doi: 10.1681/ASN.0000000766. Epub 2025 Jun 17.
Derived from this study: PubMed 39475817van Mil D, Vart P, Chertow GM, Gansevoort RT, Rossing P, Toto RD, Correa-Rotter R, Langkilde AM, Sjostrom CD, Wheeler DC, Heerspink HJL. Baseline, Early Changes, and Residual Albuminuria: Post Hoc Analysis of a Randomized Clinical Trial of Dapagliflozin in Chronic Kidney Disease. Clin J Am Soc Nephrol. 2024 Dec 1;19(12):1574-1584. doi: 10.2215/CJN.0000000000000550.
Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
Derived from this study: PubMed 38622766Fletcher RA, Herrington WG, Agarwal R, Mayne KJ, Arnott C, Jardine MJ, Mahaffey KW, Perkovic V, Staplin N, Wheeler DC, Chertow GM, Heerspink HJL, Neuen BL. Effects of Sodium-Glucose Cotransporter 2 Inhibitors on Cause-Specific Cardiovascular Death in Patients with CKD: A Meta-Analysis of CKD Progression Trials. Clin J Am Soc Nephrol. 2024 Sep 1;19(9):1180-1182. doi: 10.2215/CJN.0000000000000470. Epub 2024 Apr 16.
Derived from this study: PubMed 38580424Zhang Z, Heerspink HJL, Chertow GM, Correa-Rotter R, Gasparrini A, Jongs N, Langkilde AM, McMurray JJV, Mistry MN, Rossing P, Toto RD, Vart P, Nitsch D, Wheeler DC, Caplin B. Ambient heat exposure and kidney function in patients with chronic kidney disease: a post-hoc analysis of the DAPA-CKD trial. Lancet Planet Health. 2024 Apr;8(4):e225-e233. doi: 10.1016/S2542-5196(24)00026-3.
Derived from this study: PubMed 38564654Heerspink HJL, Stack AG, Terkeltaub R, Jongs N, Inker LA, Bjursell M, Maklad N, Perl S, Eklund O, Rikte T, Sjostrom CD, Perkovic V; SAPPHIRE Investigators. Combination Treatment with Verinurad and Allopurinol in CKD: A Randomized Placebo and Active Controlled Trial. J Am Soc Nephrol. 2024 May 1;35(5):594-606. doi: 10.1681/ASN.0000000000000326. Epub 2024 Feb 20.
Derived from this study: PubMed 38320128Koshino A, Schechter M, Chertow GM, Vart P, Jongs N, Toto RD, Rossing P, Correa-Rotter R, McMurray JJV, Gorriz JL, Isidto R, Kashihara N, Langkilde AM, Wheeler DC, Heerspink HJL. Dapagliflozin and Anemia in Patients with Chronic Kidney Disease. NEJM Evid. 2023 Jun;2(6):EVIDoa2300049. doi: 10.1056/EVIDoa2300049. Epub 2023 May 19.
redacted protocolLink provided by the sponsor.
redacted Statistical Analysis PlanLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Disease

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

390 sites in 21 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin in people with Chronic Kidney Disease, run by AstraZeneca at 390 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 390 sites in United States, Japan, China, Argentina, Canada and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the First Occurrence of Any of the Components of the Composite: ≥50% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death. (time frame: Up to 38.2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03036150, which also lists 35 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.